neonatal presentation to the pediatric emergency department

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1 Common Neonatal Presentations

• Published: October 2020
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Parents of newborns, particularly first-time parents, are often concerned that their infant has a physical examination finding or behavior that is out of range of normal. Neonates have a variety of common findings and diagnoses specific to this age group. However, their range of behaviors is limited, and they are unable to communicate, complicating evaluation. Caring for neonates in the emergency department requires knowledge of newborn-specific conditions as well as the range of normal behaviors. Common chief complaints include jaundice, feeding difficulties, vomiting, irritability and crying, breathing difficulty, and rash. Emergency department providers must be familiar with the range of normal behaviors and common diagnoses seen in neonates. This chapter presents an overview of common concerns parents have about their neonates.

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Emergency Department Visits in the Neonatal Period in the United States

Henry c. lee.

* Department of Pediatrics, Stanford University, Stanford

Naomi S. Bardach

† Department of Pediatrics, University of California, San Francisco, San Francisco, CA

Judith H. Maselli

Ralph gonzales.

§ Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA

To estimate the incidence of emergency department (ED) visits in the neonatal period in a nationally representative sample and examine variation by race.

The National Hospital Ambulatory Medical Care Survey is a nationally representative survey of utilization of ambulatory care services including EDs. We studied all ED visits for patients < 28 days from 2003 to 2008. Using National Birth Certificate data, we calculated visit rates by race. ED visits were also characterized by age, insurance status, diagnosis category, region, and hospital type (safety-net vs. non-safety net).

There was an average of 320,540 neonatal ED visits in the U.S. per year, with an estimated 7.6% of births visiting the ED within 28 days. Estimated rates of ED visits were highest among Non-Hispanic Blacks, with 14.4% (95% CI 10.0-19.2) of newborns having an ED visit in the neonatal period, compared with 6.7% (95% CI 4.9-7.2) for Whites and 7.7% (95% 5.7-9.8) for Hispanics. Hispanic and Black neonates were more likely to be seen in safety-net hospitals (75.8-78.2%) than White (57.1%) patients (p=0.004).

Conclusions

In this first nationally representative study of neonatal visits to the ED, visits were common, with the highest rates in Non-Hispanic Blacks. Hispanic and Black neonates were more commonly seen in safety-net hospitals. Reasons for high visit rates deserve further study in order to determine whether hospital discharge practices and/or access to primary care are contributing factors.

Introduction

The neonatal period (< 28 days old) is a vulnerable period of pediatric health.( 1 ) Although emergencies can certainly occur during this time period, many emergency department (ED) visits or urgent care visits may be preventable with adequate preventive hospital care in the newborn period and appropriate follow-up with a primary care provider. Non-urgent use of emergency departments may be a source of increased costs and inefficient resource utilization in healthcare.( 2 )

For newborns, hospital care after birth and early primary care may have a significant influence on healthcare utilization in the neonatal period. For instance, early discharge of newborns from the hospital has been shown to result in increased ED utilization in the first 10 days of life without a corresponding increase in re-hospitalization.( 3 , 4 ) Interventions to provide a coordinated care program with early discharge have been shown to limit ED use in infancy.( 5 ) This indicates that some of the excess ED visits may have been preventable.

Previous study has also shown that non-urgent ED visits account for up to 60% of ED visits in the first 3 months of life, with a higher proportion of use by younger and non-White mothers.( 6 ) In another study, ED visits by babies born to mothers who are single and did not attend prenatal classes were less likely to be admitted to the hospital, suggesting that those visits were not necessary, or could have been seen in a primary care setting.( 3 ) However, these studies on ED use in infancy have typically been smaller single center or health care system studies, aside from a few state-based studies and / or encompassing a period of time longer than the first month of life.( 3 - 9 )

Race and ethnicity may play a role in ED use, as Black patients in particular are more likely to visit the ED for a variety of conditions and age groups, although these differences are often attenuated after risk adjustment for various socio-demographic factors.( 10 - 12 ) The racial distribution of ED visits in the first month of life is not well known.

Our objective was to assess, in a nationally representative sample, the incidence of ED visits in the first 28 days of life overall and by race, the patient and hospital characteristics associated with neonatal ED visits, and the diagnoses seen in this group.

The National Hospital Ambulatory Medical Survey (NHAMCS) is a nationally collected survey on the utilization and provision of ambulatory care services in hospital emergency and outpatient departments. We used 2003-2008 data, the most recent NHAMCS data. We chose to use six years worth of data in order to have a large enough sample size to make comparisons between various socio-demographic groups.

In order to derive nationally representative and unbiased estimates, the NHAMCS uses a multistage probability design, which involves probability samples of primary sampling units within geographic areas, hospitals within those units, and patient visits within the hospital.( 13 )

To examine neonatal emergency department visits, we limited our analysis to those patients who were < 28 days old at the time of the visit, and to ED visits, excluding non-ED outpatient clinic visits. This data set included 619 patient visits, from which population rates were estimated, using NHAMCS survey weights. We examined visit rates and relationship to various patient and hospital characteristics of the study population as follows: race, ethnicity, sex, payer, and safety-net vs. non-safety net hospital.( 13 ) Safety-net status is defined by the Centers for Disease Control and Prevention as facilities having more than 30% of visits with Medicaid as the source of payment, more than 30% of visits with self-pay or no charge as the source of payment (i.e. uninsured), or a combined Medicaid and uninsured patient population greater than 40%.( 14 )

The NHAMCS data allows for estimation of visit rates per 1,000 persons. Because the number of births in the United States is able to be determined by birth certificate data, we were able to determine a denominator for the eligible number of newborn infants that could potentially visit the ED soon after birth. We used national data on births from the National Center for Health Statistics to calculate the total number of visits per live birth using birth certificate data.( 15 ) We used birth certificate data from the corresponding years that we had NHAMCS data, 2003 to 2008. Using the birth certificate data, we estimated ED visit rates according to self-reported maternal race / ethnicity groups. Analyses were performed with SAS 9.2 (Cary, NC) and Sudaan, version 10.0.1 (Research Triangle, NC).

We obtained all primary diagnoses for these visits in the neonatal period. The primary diagnosis as recorded in the NHAMCS record is considered one of the most important items to note in the form. While a pediatric diagnostic grouping system in the ED has been described, the system was developed using all pediatric visits types and so does not categorize the more specific concerns of the neonatal period.( 16 ) In order to categorize the neonatal visits for this study, two of the investigators independently reviewed each primary diagnosis and grouped them into categories of similar illness and systems. In cases of disagreement, there was further discussion until agreement was reached. These were broadly categorized into mild, moderate, and severe diagnoses. This process is similar to that used previously to categorize neonatal conditions either by presenting complaint or final diagnosis in ED settings.( 3 , 6 , 7 , 9 )

Diagnoses that were indicative of a birth occurring in the ED or just prior to ED arrival were excluded. Some diagnoses (n=4) were indicative of an adult diagnosis, potentially referring to a maternal condition, and were also excluded.

As data for this study were from publicly available, anonymous sources, this study was not considered human subjects research according to guidelines of the University of California, San Francisco Committee on Human Research.

There were an estimated total 1,923,245 visits over 6 years in the first 28 days of life, based on a sample of 619 records, representing an average 320,540 neonatal ED visits in the U.S. per year. This was in the context of 25.2 million births overall recorded in Birth Certificate data in the United States during the study period, for an overall rate of 7.6%. Estimated rates of ED visits were highest among Non-Hispanic Blacks, with 14.4% (95% CI 10.0-19.2) of newborns having an ED visit in the newborn period, compared with 6.7% (95% CI 4.9-7.2) for Whites and 7.7% (95% 5.7-9.8) for Hispanics.

Estimated numbers of ED visits for Non-Hispanic White, Black, and Hispanic infants by various demographic categories are shown in Table 1 . While the most common age group of visits for White and Hispanic infants was at 0-7 days of age, Black infants were more likely to be seen at 15-21 days of age, a relatively less common period of ED visits for White infants.

Patient and Hospital characteristics of neonatal emergency department visits by race.

Most neonatal ED visits occurred in safety-net hospital EDs (67%), compared with 53% of visits occurring at safety-net hospital EDs for all ages. Hispanic and Black neonates were more likely to be seen in safety-net hospitals (76-78%) than White (57%) patients (p=0.004, Table 1 ). Insurance type amongst ED visit patients was not significantly different by race / ethnicity ( Table 1 ). Patients on Medicaid represented the highest proportion for each race with neonatal ED visits.

Common reasons for “mild” ED visits included skin problems, benign gastrointestinal symptoms including jaundice, and routine care ( Table 2 ). There were no significant differences by diagnostic category and race.

Most common diagnostic categories of neonatal emergency department visits.

Our study is the first nationally representative sample estimating ED visits in the neonatal period. We found that in the United States, ED visits in the neonatal period (infants < 28 days old) were common, representing 7.7% of live births. Patients who were non-Hispanic Black were twice as likely to be seen in the ED in early infancy as White and Hispanic infants. Most neonatal ED visits occurred in safety-net hospitals, which had higher representation of Hispanic and Black patients.

For Black infants, who were twice as likely to have a neonatal ED visit, the timing of the ED visit was more likely to be not in the first week after birth, which was the most common timing of White and Hispanic infants. Interestingly, the most common timing of the ED visit for Black infants was at 15-21 days ( Table 1 ). The difference in timing of the ED visit for non-Hispanic Blacks deserves further study to understand if this is due to differences in hospital care, primary care access, or some other social or biological differences. Incidence of ED visits for Black infants was also over-represented in the South ( Table 1 ).

Non-urgent use of EDs may represent inefficient resource utilization in healthcare.( 2 ) We were not able to assess whether ED use in the NHAMCS population was non-urgent or unnecessary as it is an administrative database. While some diagnoses may appear benign, they may have presented with more worrisome symptoms. Further study is needed to assess what proportion of neonatal ED visits may be avoidable. Some visits to the ED in this period may have been more appropriate for evaluation in a non-ED / primary care clinic setting. However, the neonatal period is a vulnerable time for families and the threshold to visit an ED may be lower for this population. Ultimately, the labeling of ED visits as “unnecessary” or “non-urgent” may be an assessment that differs by parental perception of illness or injury, with some parents needing the visit and reassurance more than others. However, the finding of differences in visits by race suggests that ED visits could be reduced in those groups with higher rates. The study of infant ED visit prevention might lead to more efficient and higher quality care.

Improving the quality of care may prevent ED visits in three potential contexts: 1) prevention of newborn illness through quality of inpatient care. For example, clinicians caring for the newborn during the initial hospitalization may be able to prevent ED visits for various conditions including jaundice, infection and feeding issues, both by providing anticipatory guidance and by completing appropriate screening evaluations; 2) prevention of illness through quality of primary care and improved access to primary care. For example, early connection to a primary care provider could presumably lead to reduced ED visits, particularly for high risk populations. However, studies have been mixed on the impact of primary care programs on ED use, with one study actually showing increased ED use;( 8 , 17 ) and 3) prevention of ED visits through counseling of a parent in the hospital or clinic to recognize how and when to access primary care vs. going directly to the ED. For example, appropriate follow-up and anticipatory guidance during the newborn check-up may be particularly important in high-risk socio-demographic populations, and potentially result in reduced ED visits.( 18 ) Considering the relatively large number of neonatal ED visits, the role of each of these three areas for intervention is worthy of further study.

Patients who were on Medicaid had the highest proportion of visits for every race, with more than half of visits for Black and Hispanic infants covered by Medicaid ( Table 1 ). Therefore, this group of patients may represent an important target for further research and interventions in the above areas.

A limitation of this study is that it is a retrospective analysis and that it analyzes a sample of all visits, though they were sampled so as to provide national estimates. In addition, we were not able to account for whether the ED visit was an initial visit or a return visit, although it would be unlikely that one patient would have been sampled twice in NHAMCS during the first month of life. Data on mothers were not available, as the records were only for the infant seen in the ED. Therefore, we could not examine potentially relevant factors such as maternal age, marital status, and conditions related to the perinatal period. We also lacked data on the parental perception of illness. Although we characterized diagnoses by clinical categories, the severity of illness was ultimately not able to be determined from our data.

Because we used age as an eligibility criterion for inclusion, preterm infants who were hospitalized for a longer period of time would be less likely to be seen in the neonatal period in the ED. Preterm infants have been shown to be at higher risk of ED visits / morbidity in the first several months of life.( 9 )

There are a large number of ED visits in infants prior to 28 days old. Racial disparity exists in neonatal ED visits, with non-Hispanic Blacks having significantly higher visit rates. ED visit prior to 28 days of age may be a useful quality measure to assess hospital care and primary care in the newborn period. Tracking ED visits in the neonatal period locally and regionally may help promote improvements in the quality of care of newborns to reduce such visits, which disproportionately affect the non-Hispanic Black population.

Acknowledgments

source of funding: Henry Lee was supported by grant number K23HD068400 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Eunice Kennedy Shriver National Institute of Child Health and Human Development or the National Institutes of Health.

Abbreviations

Conflicts of interest: The remaining authors have no funding or conflicts of interest to declare.

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Review Article

Management of common newborn emergencies.

Roberto Calzada 1 , Adriana Yock-Corrales 1 * and Manuel Soto-Martínez 2

1 General Physician, Pediatric EmergencyDepartment, Hospital Nacional de Niños, Costa Rica

2 PediatricRespiratoryPhysician, Pediatric Respiratory Department, Hospital Nacional de Niños, Costa Rica

Corresponding Author

Adriana Yock-Corrales, Pediatric Emergency Department, Hospital Nacional de Niños, San José, Costa Rica.

Received Date: May 25, 2020;   Published Date: May 29, 2020

Patients in the neonatal period can present in the emergency department with many life-threatening conditions.Knowledge of these presentations by physicians that work in the emergency department is mandatory for the immediate approach of the critically ill infant. It is the responsibility of the emergency department team to identify these conditions and to stablish the best approach; this includes stabilization of the patient, differential diagnosis based, laboratory and images findings; and a well guided treatment. Serious bacterial infections, congenital cardiac disease, gastro intestinal emergencies (including malrotation with midgut volvulus and necrotizing enterocolitis), respiratory conditions, neurologic disorders and child abuse are the most common diagnosis in this type of scenarios. The main objective of this article is to review the most common conditions of the critical ill infant in the emergency department.

Keywords: Bronchopulmonary dysplasia; Tyrosine-Protein Kinase Kit; Vascular endothelial growth factor; Pulmonary fibrosis, type II collagen; CD31

Abbreviations: NHS: National Health Service of the Dominican Republic; SIBEN: Iberoamerican Society of Neonatology; NB: Newborn; PH: Pulmonary hemorrhage; RCA: Root cause analysis; NICU: Neonatal intensive care unit

• Introduction

Non-serious conditions are the cause of the majority of visits to the emergency department (ED) in these age group patients [1]. Although infection is the most reported cause of the ill appearance among neonates and young infants, there are other clinical conditions that have similar presentations and also represents serious entities of an unwell infant [2,3]. The ED personnel should be ready to identify conditions that increased the mortality in this population, and to have a step-approach to follow in this case without delaying treatment.

• Recognition and Approach of the Critically Ill Neonate

Clinical history

The first step for any crucial diagnosis is the clinical history. The physician should always check for prenatal, perinatal and postnatal history. Prolonged membrane rupture or perinatal maternal fever is an important risk factor for sepsis. Prematurity and low birth weight are one of the major contributors to infant mortality [4,5]. Other important information is the Apgar score and need for resuscitation at birth, weight gain in the first week, frequency in urination and bowel movements, as well as feeding.Any change in the patient normal pattern could mean a serious condition that might need further evaluation.

Physical examination

A complete physical examination can help detecting anomalies that may risk the newborn life. Evaluation of neonatal size, weight, and vital signs as heart rate, respiratory rate, oxygen saturation level, blood pressure and temperature are necessary. The Pediatric Assessment triangle (PAT) is a well stablished method for rapid assessment that should be done in every child in the ED, this triangle includes theevaluation of the infant’s appearance, work of breathing and circulation to skin [6,7] (Figure 1).

Evaluation of the airway and breathing is very important. Work of breathing, respiratory rate and auscultation is essential. The normal respiratory rate is 40 to 60 breaths per minute in neonates. Physicians should verify that the patient has adequate ventilation and oxygenation, as well as need for positioning and suctioning. Abnormal sounds (snoring, grunting, stridor, audible wheeze and any abnormal sounds) associated with signs of increase work of breathing (sniffing position, nasal flaring, retractions, paradoxical chest movements) has to be interpreted as signs of respiratory distress [8].

Circulation, including hydration status, capillary refill time (normal less than 2 seconds), and heart rate should be evaluated. The normal neonatal heart rate is between 120 and 160 beats per minute, and the systolic blood pressure 60 to 90 mmHg [8]. Hypotension is a late finding in a patient with shock.

A direct guided neurological examination should be performed. Some aspects that should be included are muscular tone, cranial nerves, primitive reflexes and consciousness (Table1). Seizures may indicate abnormalities including low glucose and abnormal electrolyte levels, central nervous system infections, and metabolic disease [9].

Table 1: Common developmental reflexes in the newborn.

Assessment of the abdomen and genitourinary tract is also something that has to be done. The liver border is frequently palpated approximately 1 cm below the right costal margin. The umbilical cord has to be inspected looking for signs of infection and bleeding. Male infants should be evaluated for hypospadias or other urethral anomalies, inguinal hernias, varicoceles, hydroceles and undescended testis [10].

Skin conditions are a frequent consultation in the ED. The most common is erythema toxicum neonatorum, occurring in almost 20- 50% of the newborns; is a common pustular eruption seen in term neonates within the first 72 hours of life that resolves spontaneously within one week [11]. Abnormal skin color should be evaluated, especially when jaundice appears. Jaundice can be associated with life threatening illness like sepsis or metabolic disease [12].

The first step in assessing the critically ill neonate is the first impression with the PAT. The first impression includes aparience, respiratory effort and circulation to the skin. After PAT, the primary assessment follows with evaluation of airway, breathing, circulation, disability and exposure (ABCDE). The physician has to check for vital signs, placement of a cardiac monitor and pulse oximeters; bedside testing of blood glucose should be done promptly [13]. Delivery of oxygen by high flow mask may be sufficient to reverse hypoxia in the ill neonate. If no peripheral intravenous lines can be established, either an intra-osseous line or umbilical catheter must be placed. When saline boluses are required, the physician initially should begin with 5-10ml/kg and then check on vital and clinical signs of perfusion.Normal neonatal glucose goes above 35-40 mg/ dl, below that number is considering hypoglycemia [14] (Figure 2).

Laboratory tests are needed when there is a clinical suspicion, but in the ill neonate there are unspecific signs and symptoms that vary alongside the different diseases. Electrolytes, serum glucose, and calcium level; a complete blood cell count (CBC); pro-thrombin time (PT); partial thromboplastin time (PTT); and blood cultures should be considered once IV access. Other tests may be considered depending on the differential diagnosis [3].

Infectious disease emergencies: Congenital infections and neonatal sepsis are important conditions in this age group.It is estimated that 12.5% of febrile infants have a serious bacterial infection and the incidence in pediatric population younger than 28 days may be as high as 20% [15,16].

Neonatal sepsis can be associated withhigh mortality and morbidity. It can be classified in early onset sepsis (EOS) and late onset sepsis (LOS). EOS is present in the first week of life and is associated with vertical transmission, being the vaginal bacteria flora of the mother the most common source [17]. The risk factors are prolonged membrane rupture (>18 hours), maternal age >35 years, cesarean section, chorioamniotis, maternal B streptococcal colonization, maternal fever and presence of sexually transmitted disease. Group B streptococcus and E. coli are the most common bacteria in early onset sepsis, alongside with other microorganism found in Table 2 [18].

Table 2: Most common agents in EOS and LEOS.

LOS is presented from day 7 to 28 days of life and it is not usually associated with complications in the obstetric scenario, therefore these neonates may have risk factors that can be identified as triggers. For example, disruption of the skin or mucosa due to invasive procedures (intravascular catheter) increases the risk of late-onset infection.In LOS, Gram-positive bacteria are the most common, in this case CoNS, S.aureus and Enterococcus species are the ones with general higher incidence.

Table 3: Clinical Presentation of a Septic Neonate.

Clinical presentation: Clinical manifestations vary from subtle symptoms to septic shock. Most of the signs and symptoms are nonspecific and are listed in Table 3. The physical examination should look for the source of infection; changes in basal temperature are the most common clinical finding. In full term infants hyperthermia is more common than hypothermia. Lethargy, irritability, and decreased oral intake are important findings related to neonates with a septic condition [19]. It is estimated that 85 percent of newborns with EOS, have signs of respiratory distress (tachypnea, grunting, flaring, use of accessory muscles).

Management and treatment of neonatal sepsis: Management should start with the evaluation of ABCDE with interventions depending on the abnormality found. Standard laboratory tests for the neonate with suspected sepsis are described in table 4. The immature-neutrophil to total neutrophil ratio greater than 0.2 is 60 to 90% sensitive and 70%-80% specific for the diagnosis of neonatal sepsis. It is recommended that the urine sample collection for the urinalysis, should be done via bladder catheterization or supra-pubic aspiration, to reduce the rate of contaminated samples. When respiratory symptoms are noted, a chest x-ray is indicated. If the patient presented with diarrhea, an initial stool sample must be performed [3].

Inflammatory markers are not specific to sepsis and have limitations. For example CRP is a marker of inflammation therefore is not limited to sepsis, and will be positive at least 8-10 hours after the sepsis started.The step-by-step approach (Figure 3) makes it easier to classify the patient’s risk. This algorithm evaluates febrile infants aged 0 to 90 days and organized them in low, intermediate or high risk patients. The factors that are included are sequentially: general appearance of the infant, the age, urinalysis and, the results of blood biomarkers, including PCT, CRP, and absolute neutrophil count (ANC). If any patient does not complete at least one of the criteria that is listed in the algorithm for low risk, it is immediately classified as high risk and needs a complete diagnostic evaluation [16,20].

Treatment with empiric antibiotics should be started. Ampicillin and gentamycin are the preferred empiric therapy. If there is a need to add another antibiotic a third-generationcephalosporin can be added depending on the antibiotic resistance and type of infection. In cases of LOS it its recommended coverage with vancomycin combined with aminoglycoside [21,22].

Bacterial meningitis in children is one of the most challenging and high-risk condition in the ED. Group B Streptococcus (GBS) and Escherichia coli are the most common causative agents in neonates and mortality rate is around 6.9% [23]. Listeria monocytogenes, non-typeable H influenzae, and group A Streptococcus are uncommon in this period of life. Neonates, young infants, and immunocompromised older children are at highest risk. Nowadays, the use of intrapartum antibiotics to prevent neonatal GBS infection has reduced its prevalence in the neonatal period.Common bacterial meningitis pathogens are: Group B Streptococcus (39%), Gram-negative bacilli (32%), Streptococcus pneumonia (14%) and Neisseria meningitidis (12%) [23].

Clinical presentation: b> Fever, vomiting, seizures, and altered mental status are the predominant signs of meningitis in the neonatal age, symptoms sometimes can be subtle so every patient with less than 28 days with suspected sepsis should always be screened for meningitis [23].

Management and treatment: ABC´s (airway, breathing, and circulation) is a standard procedure on the initial evaluation and stabilization of the patient, alongside with intravenous (IV) and antibiotics [23]. Lumbar puncture with CSF analysis and culture, peripheral blood cultures and other specific laboratory markers such as procalcitonin are needed to increase the sensitivity of the diagnosis confirmation by laboratory test. According to some literature, the median CSF WBC count was significantly higher in infants aged less than 28 days (3 cells/mcL; 95th percentile, 19 cells/mcL) than in infants aged 29 to 56 days (2 cells/mcL; 95th percentile, 9 cells/mcL, P < .001) [23].

Appropriate initial empiric coverage includes ampicillin and Cefotaxime. It is not common for neonates to have meningitis caused by methicillin-resistant Staphylococcus aureus (MRSA) or resistant S. pneumonia, however if there is a suspected meningitis by one of this two agents, vancomycin can also be added. Finally, there is limited evidence for the use of routine adjuvant steroids, therefore it is not recommended for treatment of neonatal meningitis [23].

Neonatal herpes (HSV)

Neonatal herpes is an uncommon infection occurring in 1 of every 32000 deliveries and presents between the second and third week of life. The most common risk factor is birth to an HSV infected mother; it represents a higher risk being born with vaginal delivery in mothers with primary genital infection [24].

Three clinical manifestations are important for the prediction of morbidity and mortality. First the disseminated type, in which multiple organs including the liver, lung, adrenal glands, skin, eye, and brain (60 to 75 % of disseminated HSV) are involved; and it represents 25% of HSV infections.The second is CNS infection without disseminated disease, but can also be associated with skin, eyes and mouth manifestations; it occurs in 30% of HSV infections. The third one is the skin, eye, or mouth disease and it represents approximately 45% of HSV disease; this one does not include CNS or disseminated HSV infection. Risk factors for neonatal HSV are: duration of rupture membranes, integrity of cutaneous barrier, maternal antibody status, vaginal delivery and type of HSV (HSV 1 vs. 2) [25,26].

Table 4: Standard laboratory and image tests for suspected neonatal sepsis.

Table 5: Recommended antibiotics and dosages for neonatal sepsis.

HSV cultures, PCR and whole blood sample are recommended. Laboratory definitive diagnosis is made by the isolation of HSV through culture, but PCR for HSV detection is more sensitive than viral culture in the CSF and blood, therefore it is the preferred test for disseminated and central nervous system HSV presentation. Tzanck test and detection of HSV antigen by direct immunofluorescence assay are not sensitive for HSV infection, therefore it is not recommended and should be avoided [27]. Treatment should start with supportive care, initial empiric broad spectrum antibiotics and administration of acyclovir. Initiation of treatment has shown to decrease mortality from 90 to 31% (Table 5).

Gastrointestinal emergencies (GI): There are clinical manifestations of the GI tract that may increase the probability of a serious illness.Vomiting (especially bilious), diarrhea, GI bleeding, and jaundice alongside with hemodynamic instability are symptoms that should raise concern in an ED. Malrotation in neonates including volvulus and duodenal obstruction, necrotizing enterocolitis and biliary atresia are some of the most common GI emergencies in the newborn period.

Intestinal malrotation (volvulus and duodenal obstruction)

Volvulus occurs when the small bowel twists around the superior mesenteric artery compromising its vascularity and producing small bowel ischemia. It is estimated that one-third of children with malrotation in the neonatal period, are at risk of presenting a volvulus [21]. In neonates, malrotation can also be presented as duodenal obstruction. It is produced by Ladd bands which cross the duodenum or by association of duodenal atresia and stenosis [28-30].

Clinical presentation: Volvulus usually presents with bilious vomiting and abdominal distention. It is common an acute presentation, but it can also be presented in a chronic way with episodic vomiting and abdominal pain, suggesting intermittent volvulus. The symptoms may vary, when the infant is younger at the time of presentation. Other symptoms include, loss of appetite, apneas, constipation and poor growth (31) The necrotic bowel can cause a third space fluid losses and also septic shock, with hemodynamic compromise. On the other hand, even though duodenal obstruction shares a similar vomiting characteristic (bilious), it is usually presented without abdominal distension. In a neonate, bilious vomiting is a surgical emergency until proven otherwise [29].

Management and treatment: When malrotation is suspected a complete blood cell count, electrolytes, blood urea, nitrogen, creatinine and blood group should be taken. Usually these patients are presented with dehydration, acidosis and elevated WBC [28]. The diagnostic test of choice is an upper gastrointestinal (UGI) study, which has a sensitivity of 96% for malrotation. Some positive signs of malrotation are the classic bird-beak sign and the corkscrew pattern in the dilated proximal duodenum with contrast. Abdominal radiographs findings are not specific, but a distended bubble of air in stomach and duodenum with gasless abdomen are common findings in malrotation. Free air may be observed when there is a perforated segment from the ischemic bowel [28].

Initial treatment should be focused in fluid and electrolyte replacement and a nasogastric tube should be place.The definite treatment is the surgical resolution and antibiotics are needed to be administered if there are signs of peritonitis and shock [32].

Necrotizing enterocolitis

Necrotizing enterocolitis (NEC) is one of the most common gastrointestinal emergencies in the neonatal period and is usually seen in premature infants. It is common in the first 10 days of life and it consists in an ischemic necrosis of the intestinal mucosa associated with severe inflammation, invasion of enteric gas forming organisms, and dissection of gas into the bowel wall and portal venous system. It is a condition with high mortality, overall between 20% and 40%. Its etiology is multifactorial [33].

Clinical presentation: Usually it is presented in preterm infants, although a 10% of cases occur in term newborns. (ref) The most frequent sign of NEC is an acute change in feeding tolerance with association of other clinical manifestations like ill appearance infant, with irritability, lethargy, anorexia, bloody stools and distension of the abdomen.

Management and treatment: Laboratory findings can be helpful in making the diagnosis of NEC. Findings are often anemia with leukocytosis, thrombocytopenia, evidence of disseminated intravascular coagulopathy (DIC), and in 20% of cases a positive blood culture. Also, electrolytes abnormalities can be present [33,34].

For diagnostic issues, a plain radiograph of the abdomen is usually used to confirm the diagnosis of NEC with intraluminal gas, portal venous gas, free intra-peritoneal gas, and dilated loops of bowel, bowel wall thickening, and perforation which can occur in 12%-30% of patients. Ultrasonography has become a very useful tool in these cases because it aloud to detect free fluid [33].

Treatment of NEC includes an orogastric or nasogastric tube, antibiotics with anaerobic and gram-negative coverage (ampicilin, gentamycin, metronidazole), and aggressive hydration. Surgical intervention is indicated when pneumoperitoneum is present. Patients with NEC but without pneumoperitoneum can be followed up with repeated radiographs every 6 to 8 hours to check on NEC progression [3].

Neurological emergencies in neonates: Neurologic emergencies in a newborn can be manifested with unspecific and subtle symptoms, for example changes in the feeding pattern only.

Neonatal seizures are often difficult to treat. It usually addresses a neurological specific condition, most commonly perinatal hypoxia-ischemia which accounts for approximately 50- 60%, and usually starts in the first 24 hours after birth. Mortality ranges from 15 - 40% [37]. Intracranial infections are responsible for 5% to 10% of neonatal seizures. Nonbacterial etiologies include toxoplasmosis, cytomegalovirus, and herpes simplex. Bacterial infections include a group already discussed earlier. Any infant with symptoms of sepsis should have a septic work-up (including blood, urine, and cerebrospinal fluid (CSF) cultures. [38] Intracranial hemorrhage account for 10% of all cases, specially matrix intraventricular hemorrhages, and metabolic disturbances. Inborn errors of metabolism like a defect in pyridoxine metabolism might produce seizures in the neonatal period that will not ceased with antiepileptic drug therapy [38-40]. Causes of seizures in the neonatal period are shown in Table 6.

Table 6: Causes of Neonatal seizures.

Management and treatment: In the immediate care of a seizure the physician should first prioritized the stabilization of the airway, followed by breathing and circulation status (ABC’s). If the respiratory system is compromised, supplementation of oxygen should be administered and getting blood glucose measurement is essential. If hypoglycemia is documented a bolus of 10% dextrose of 2-4ml/kg should be indicated [41].

Laboratory tests should include guided causes of differential diagnosis such as metabolic disorder (glucose, sodium, calcium and magnesium levels). Other tests may include hematocrit, electrolytes, blood urea and nitrogen, phosphate, serum ammonia, blood gases and possibly blood cultures and lumbar puncture [12].

The first line of treatment in seizures is benzodiazepines like Lorazepam. If the seizure does not stop second line treatment is indicated (Phenobarbital), if it is not sufficient a third line such as Fosphenytoin or Phenytoin can be use (Table 6). If presented with refractory status epilepticus, the clinician will need to manage and secure the airway, start Midazolam infusion and prioritize this patient for the intensive care unit admission [40]. Pyridoxine (Vitamin B6) can be administered if there is persistence of the seizures, at 100mg dosage. Acyclovir can be added in the presence of encephalitis [31](Table 2).

Further studies like cranial computed tomography can be done after the seizure event stopped, if there is no clear cause of the seizure, also cranial ultrasound looking for the identification of intracranial hemorrhage, and also EEG is often required [38] (Table 7).

Table 7: Pharmaceutical management of neonatal seizures.

Many neonatal serious conditions may vary in presentation, but most of them are initially non-specific. The promptly recognition and knowledge of atypical features can improve the approach and give an earlier diagnosis. Every ED should always stablish an early communication with the pediatric or neonatal unit for a possible transfer in the second part of this article respiratory and cardiological conditions will be reviewed.

• Acknowledgement
• Conflict of Interest

No conflict of interest.

Table 1: Least Squares Means (Standard Errors) for Lifetime Substance Use in the Total Sample and Least Squares Means (Standard Errors) for Lifetime Substance Use, Tests of Significance, and p Values for Girls and Boys (N=394).

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• Whitley RJ, Corey L, Arvin A, Lakeman FD, Sumaya CV, et al. (1988) Changing presentation of herpes simplex virus infection in neonates. J Infect Dis 158(1): 109-116.
• Caviness AC, Demmler GJ, Selwyn BJ (2008) Clinical and laboratory features of neonatal herpes simplex virus infection: a case-control study. Pediatr Infect Dis J 27(5): 425-430.
• Ratnayake K, Kim TY (2014) Evidence-based management of neonatal vomiting in the emergency department. Pediatr Emerg Med Pract 11(11): 1-20.
• Nehra D, Goldstein AM (2011) Intestinal malrotation: varied clinical presentation from infancy through adulthood. Surgery 149(3): 386-393.
• Fonkalsrud E (2003) Rotational anomalies and volvulus. In: Principles of Pediatric Surgery, O'Neill JA et al. (Ed), Mosby, St. Louis.
• Brousseau T, Sharieff GQ (2006) Newborn emergencies: the first 30 days of life. Pediatr Clin North Am 53: 69-84.
• Liu LM, Pang LM (2001) Neonatal surgical emergencies. Anesthesiol Clin North America 19(2): 265-286.
• Lim JC, Golden JM, Ford HR (2015) Pathogenesis of neonatal necrotizing enterocolitis. Pediatr Surg Int 31: 509-518.
• Kenton A (2005) Severe thrombocytopenia predicts outcome in neonates with necrotizing enterocolitis. J Perinatol 25(1): 14-20.
• Park E, Pearson NM, Pillow MT, Toledo A (2014) Neonatal endocrine emergencies: a primer for the emergency physician. Emerg Med Clin North Am 32(2): 421-435.
• American Academy of Pediatrics Subcommittee on Hyperbilirubinemia (2004) Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics 114(1): 297-316.
• Stafstrom CE (1995) Neonatal seizures. Pediatr Rev 16: 248-255.
• Zupanc ML (2004) Neonatal seizures. Pediatr Clin North Am 51: 961-978.
• Cockburn F, Brown JK, Belton NR, Forfar JO (1973) Neonatal convulsions associated with primary disturbance of calcium, phosphorus, and magnesium metabolism. Arch Dis Child 48(2): 99-108.
• Maytal J, Novak GP, King KC (1991) Lorazepam in the treatment of refractory neonatal seizures. J Child Neurol 6(4): 319-323.
• Adamkin DH (2016) Neonatal hypoglycemia. Curr Opin Pediatr 28(2):150-155.
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• DOI: 10.33552/GJPNC.2020.02.000537
• Volume 2 - Issue 3, 2020
• Open Access

Roberto Calzada, Adriana Yock-Corrales, Manuel Soto-Martínez. Management of Common Newborn Emergencies. Glob J of Ped & Neonatol Car. 2(3): 2020. GJPNC.MS.ID.000537.

Emergency department, Newborn, Infant, Patients, Mortality, Child, Neonatal seizures, Neonatal sepsis, Risk factors

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The factors affecting neonatal presentations to the pediatric emergency department

Affiliations.

• 1 Division of Rheumatology, Department of Pediatrics, Hacettepe University Medical Faculty, Ankara, Turkey.
• 2 Division of Emergency Medicine, Department of Pediatrics, Hacettepe University Medical Faculty, Ankara, Turkey.
• PMID: 25648054
• DOI: 10.1016/j.jemermed.2014.12.031

Background: A pediatric emergency department (PED) may be utilized by neonates for nonurgent complaints. Various factors, such as primiparity, maternal age, early postnatal discharge, race, income, and maternal and paternal educational levels, have been reported to affect the acuity of neonatal emergency department utilization.

Objective: To determine the characteristics of PED visits by neonates (infants ≤ 28 days of age) and to evaluate the factors affecting the acuity of these visits.

Methods: We prospectively collected the data of neonates who were admitted to the PED of a tertiary university hospital within a 6-month period. Presenting problems were classified as acute if diagnostic tests were requested or the patient was hospitalized, unless the final diagnosis was "normal newborn."

Results: Over this period, 28,389 children (0-18 years of age) visited the PED, of which 531 were newborns (1.9%). The mean age was 14.1 ± 8.3 days, with a slight predominance of males (57.3%). The chief complaints were jaundice (23.4%), irritability (9.5%), and vomiting (7.1%), and the most common diagnoses were normal newborn (33.9%), indirect hyperbilirubinemia (13.2%), and colic (5.8%). Acute visits were 55.7% of the total visits. Premature infants, infants of multiparous mothers, infants of older mothers (≥25 years), and physician-referred infants were more likely to present with acute problems (p values were 0.001, 0.013, 0.006, and <0.001, respectively).

Conclusion: The results suggest that there may be a relationship between nonacute neonatal visits to a PED and insufficient knowledge of the caretaker on newborn care. Thus, more detailed education and early postnatal support programs regarding newborn care may help to decrease nonacute PED visits by neonates.

Keywords: acute visit; emergency department; newborn; prematurity; primiparity.

Copyright © 2015 Elsevier Inc. All rights reserved.

• Acute Disease
• Colic / complications
• Colic / diagnosis
• Emergency Service, Hospital / statistics & numerical data*
• Hospitalization / statistics & numerical data
• Hospitals, Pediatric / statistics & numerical data*
• Hyperbilirubinemia / complications
• Hyperbilirubinemia / diagnosis
• Infant, Newborn
• Infant, Premature
• Irritable Mood*
• Jaundice, Neonatal / etiology*
• Maternal Age
• Patient Acuity
• Prospective Studies
• Referral and Consultation
• Tertiary Care Centers
• Vomiting / etiology*
• Young Adult

• Introduction
• Article Information

RCT indicates randomized clinical trial.

eFigure. Core Search Strategy for Structured Literature Search

eTable. Additional RCT Questions, Ranked by Overall Score

Nonauthor Collaborators

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Coon ER , McDaniel CE , Paciorkowski N, et al. Prioritization of Randomized Clinical Trial Questions for Children Hospitalized With Common Conditions : A Consensus Statement . JAMA Netw Open. 2024;7(5):e2411259. doi:10.1001/jamanetworkopen.2024.11259

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Prioritization of Randomized Clinical Trial Questions for Children Hospitalized With Common Conditions : A Consensus Statement

• 1 Department of Pediatrics, Intermountain Primary Children’s Hospital, Salt Lake City, Utah
• 2 Department of Pediatrics, University of Utah School of Medicine, Salt Lake City
• 3 Division of Hospital Medicine, Department of Pediatrics, Seattle Children’s Hospital, University of Washington, Seattle
• 4 Department of Pediatrics, Rochester General Hospital, Rochester, New York
• 5 Section of Hospital Medicine, Children’s Hospital Colorado, University of Colorado, Aurora
• 6 Section of Emergency Medicine, Children’s Hospital Colorado, University of Colorado, Aurora
• 7 Division of Hospital Medicine, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio
• 8 The Hospital for Sick Children and Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada
• 9 Pediatric Hospital Medicine, University of Florida COM-Jacksonville, Jacksonville
• 10 Department of Pediatrics, St Charles Hospital, Bend, Oregon
• 11 Division of Pediatric Hospital Medicine, Stanford University School of Medicine, Stanford, California
• 12 Dartmouth Health, Geisel School of Medicine at Dartmouth College, Lebanon, New Hampshire
• 13 Division of Pediatric Hospital Medicine, University of Nebraska Medical Center, Omaha
• 14 Division of Pediatric Hospital Medicine, University of California, San Francisco
• 15 Department of Pediatrics, Golisano Children’s Hospital, Rochester, New York
• 16 Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, New York

Question   What are the most important and feasible randomized clinical trial (RCT) questions for children hospitalized with common conditions?

Findings   In this consensus statement, a 3-stage modified Delphi process involving multidisciplinary input from 46 individuals across 30 institutions produced 62 unique RCT questions, ranked according to importance and feasibility.

Meaning   These RCT questions can guide investigators and funders in conducting impactful trials to improve care and outcomes for children hospitalized with common conditions.

Importance   There is a lack of randomized clinical trial (RCT) data to guide many routine decisions in the care of children hospitalized for common conditions. A first step in addressing the shortage of RCTs for this population is to identify the most pressing RCT questions for children hospitalized with common conditions.

Objective   To identify the most important and feasible RCT questions for children hospitalized with common conditions.

Design, Setting, and Participants   For this consensus statement, a 3-stage modified Delphi process was used in a virtual conference series spanning January 1 to September 29, 2022. Forty-six individuals from 30 different institutions participated in the process. Stage 1 involved construction of RCT questions for the 10 most common pediatric conditions leading to hospitalization. Participants used condition-specific guidelines and reviews from a structured literature search to inform their development of RCT questions. During stage 2, RCT questions were refined and scored according to importance. Stage 3 incorporated public comment and feasibility with the prioritization of RCT questions.

Main Outcomes and Measures   The main outcome was RCT questions framed in a PICO (population, intervention, control, and outcome) format and ranked according to importance and feasibility; score choices ranged from 1 to 9, with higher scores indicating greater importance and feasibility.

Results   Forty-six individuals (38 who shared demographic data; 24 women [63%]) from 30 different institutions participated in our modified Delphi process. Participants included children’s hospital (n = 14) and community hospital (n = 13) pediatricians, parents of hospitalized children (n = 4), other clinicians (n = 2), biostatisticians (n = 2), and other researchers (n = 11). The process yielded 62 unique RCT questions, most of which are pragmatic, comparing interventions in widespread use for which definitive effectiveness data are lacking. Overall scores for importance and feasibility of the RCT questions ranged from 1 to 9, with a median of 5 (IQR, 4-7). Six of the top 10 selected questions focused on determining optimal antibiotic regimens for 3 common infections (pneumonia, urinary tract infection, and cellulitis).

Conclusions and Relevance   This consensus statementhas identified the most important and feasible RCT questions for children hospitalized with common conditions. This list of RCT questions can guide investigators and funders in conducting impactful trials to improve care and outcomes for hospitalized children.

Randomized clinical trials (RCTs) are the criterion standard design to determine the efficacy or effectiveness of a given intervention. Although the number of RCTs involving adult participants has increased over time, the number of RCTs involving children has stalled in the last 2 decades. 1 The relative lack of RCTs including children results in pediatric clinicians more often having to make medical decisions based on observational studies, adult studies, or expert opinion.

Children are vulnerable to morbidity and mortality while hospitalized, making hospitalized children a priority population for RCTs. The pediatric RCTs that have led to the greatest recent improvements in outcomes for hospitalized children have focused on novel therapeutics for severe but relatively uncommon conditions, such as cystic fibrosis 2 and neuromuscular disease. 3 Randomized clinical trials for the most common pediatric conditions that lead to hospitalization are comparatively scarce. 4 For example, based on prevalence of disease, there are several hundred fewer RCTs than would be expected for childhood respiratory infections. 4

A first step toward conducting more RCTs involving common pediatric conditions for hospitalized children is to prioritize research questions for researchers and funders. The objective of this consensus statement was to identify the most important and feasible RCT questions for children hospitalized with common conditions.

In this consensus statement, we report on a 3-stage modified Delphi process conducted from January 1 to September 29, 2022 ( Figure ), and modeled after previous prioritization efforts incorporating clinician, researcher, and patient-parent perspectives. 5 - 7 Construction of RCT questions occurred during stage 1, followed by evaluation of trial question importance in stage 2 and feasibility in stage 3. This study was reviewed by the University of Utah institutional review board and received an exemption determination because the research included only interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior. Participants provided written consent and were offered a $250 gift card for participating in the conference series.

We used purposive sampling to recruit study participants. The study team developed an initial expertise-based list of clinicians and researchers who were invited to participate. Patient-parent partners with affiliations to the study team and their institutions were also invited to participate. We then used a snowball sampling procedure to recruit participants with additional perspectives and expertise as needed. Participant race and ethnicity were reportedby the participants themselves. The US Department of Health and Human Services Office of Minority Health categories for race and ethnicity were used. These variables were collected as a measure of the diversity of conference participants. Ensuring a diversity of backgrounds and perspectives was prioritized in recruitment. For example, in addition to diversity of gender, race, and ethnicity, we sought diversity by clinical background (eg, nurses, pharmacists, and physicians) and practice environment (eg, children’s hospital and community hospital). Inclusion of community hospital participants was a priority because most children, particularly those hospitalized for common conditions, receive their care in settings other than freestanding children’s hospitals. 8

We began stage 1 of our modified Delphi process in January 2022 by identifying common pediatric conditions to serve as the basis for generating RCT questions. We used national hospitalization utilization data to identify the 10 most common pediatric conditions leading to hospitalization. 9 , 10 We excluded conditions for which surgical or other specialist clinicians may lead management (eg, appendicitis, diabetic ketoacidosis, and epilepsy). After applying this exclusion, we found that the 10 most common pediatric conditions (in decreasing order of prevalence) were birth hospitalization, bronchiolitis, pneumonia, asthma, mood disorders, cellulitis, neonatal hyperbilirubinemia, urinary tract infection, gastroenteritis, and septicemia. Together, these conditions accounted for more than 75% of all pediatric hospitalizations annually in the US. 9 , 10

A medical librarian (E.F.) performed structured literature searches for each condition. The medical librarian hand-searched the reference lists provided with each condition’s diagnosis and treatment summaries in Dynamed and UpToDate, 2 evidence-based clinical resources. Next, the librarian created structured literature searches in PubMed to capture relevant guidelines or evidence syntheses for each condition. The core strategy is available in the eFigure in Supplement 1 . Four authors (E.R.C., C.E.M., N.P., and S.V.K.) with pediatric hospital medicine expertise reviewed the search results and selected 3 to 5 high-yield resources for each condition that were most pertinent to understanding the evidence gaps related to diagnosis or management of each condition. For example, clinical practice guidelines with a section devoted to evidence gaps or research needs existed for most conditions and were included in the high-yield resources.

We divided participants into small groups (n = 10) for each condition, making sure that community and children’s hospital clinicians were represented in each small group. Each small group had at least 1 researcher with peer-reviewed publication expertise for that condition. Small groups had 2 months to review their high-yield resources, share additional resources with one another, and meet virtually to generate a list of at least 3 RCT questions for their assigned condition.

We conducted a virtual conference in June 2022 for stage 2 of our modified Delphi process. The purpose of stage 2 was to refine the RCT questions generated in stage 1 and evaluate them in terms of importance. Stage 2 was grounded within a framework of 6 guiding questions ( Box 1 ). This framework mirrored existing quality domains developed by the National Academy of Medicine. 11 Small groups took turns presenting their RCT questions to conference participants, sharing their impression of the importance of each question, receiving input from conference participants, and refining the questions. For each condition, patient-parent partners were asked to comment on patient centeredness of the presented RCT questions. We prioritized parent input within the discussion of each condition to ensure RCT questions were relevant and important to families. At the conclusion of the first conference, individual participants anonymously scored all the RCT questions for importance on a scale of 1 to 9, with 9 indicating the highest level of importance. To establish external validity of the generated questions, the RCT questions were then distributed for public comment to the American Academy of Pediatrics Society of Hospital Medicine listserv (approximately 4000 members). We invited listserv members to provide input and feedback on the generated questions through 3 mechanisms: (1) scoring each question on the same importance scale, (2) providing commentary on the questions, and (3) offering suggestions of additional important questions for consideration.

Framework for Evaluating the Importance of the RCT Question

To what extent will this RCT…

Answer a question that patients and their families care about (patient centeredness)?

Improve the patient experience?

Improve important clinical outcomes?

Increase efficiency or reduce variation in care delivery?

Improve safety?

Promote diversity, equity, and inclusion?

Abbreviation: RCT, randomized clinical trial.

We conducted a second virtual conference in September of 2022 for stage 3 of our modified Delphi process. The purpose of stage 3 was to incorporate feasibility into the prioritization of the RCT questions. The public comment and ratings of RCT questions generated in stage 2 were reviewed for incorporation and consideration. Small groups were given time to discuss the feasibility of their RCT questions guided by 3 core questions ( Box 2 ). Small groups group-scored each of their RCT questions on a feasibility scale of 1 to 9, where scores higher than 6 indicated RCT questions that were feasible for all 3 core feasibility questions, scores of 4 to 6 indicated RCT questions with a feasibility concern in 1 core feasibility question, and scores lower than 4 indicated RCT questions with a feasibility concern in more than 1 core feasibility question. Small groups then reported to the full group of conference participants, sharing their impressions and scores for the feasibility of each RCT question, with further input from conference participants.

Framework for Evaluating the Feasibility of the RCT Question

How straightforward, or not, would it be to administer the proposed intervention and control group requirements at your institution? Are the intervention and controls doable at your institution?

In your usual practice, how commonly do you care for patients who would be eligible for this trial (eg, weekly, monthly, and yearly)?

What challenges, if any, do you anticipate for collection of outcomes data in this trial?

At the conclusion of this conference, participants were provided the summary scores and comments related to the importance and feasibility of each question and asked to submit a final overall score for each question. This scoring was individual and anonymous, using a 1 to 9 scale, with higher scores indicating the most important and feasible RCT questions.

A total of 46 individuals from 30 different institutions participated in our modified Delphi process. Participants included children’s hospital (n = 14) and community hospital (n = 13) pediatricians, parents of hospitalized children (n = 4), other clinicians (ie, nurse and pharmacist; n = 2), biostatisticians (n = 2), and other researchers (eg, trialists and research coordinators; n = 11). Pediatric clinical expertise represented by these participants included hospital medicine (n = 27), general pediatrics (n = 3), infectious disease (n = 2), emergency medicine (n = 1), and critical care (n = 1). Participant geographic representation included Canada (n = 4) and all 4 US Census Bureau regions: West (n = 24), Midwest (n = 7), Northeast (n = 7), and South (n = 4). Conference participants who shared their demographic data (n = 38) self-identified as women (24 of 38 [63%]) and men (14 of 38 [37%]) and as having the following races and ethnicities: Asian ([4 of 38] 11%), Black or African American ([3 of 38] 8%), Hispanic ([2 of 38] 5%), Native Hawaiian or Other Pacific Islander ([1 of 38] 3%), and White ([30 of 38] 79%). A total of 115 listserv respondents provided comments and/or ratings of RCT questions generated in stage 2 of the modified Delphi process.

This process produced 62 unique RCT questions. Participant scores for the importance of each RCT question ranged from 1 to 9, with a median of 5 (IQR, 3-7). Participant overall scores, incorporating both importance and feasibility of the RCT question, ranged from 1 to 9, with a median of 5 (IQR, 4-7). The 10 RCT questions with the highest overall mean scores are summarized in the Table in a PICO (population, intervention, control, and outcome) format. The remaining 52 questions generated by this work and their mean scores are displayed in the eTable in Supplement 1 .

A total of 7 of 62 questions (11%) scored higher than 6 for importance. Five of those questions also had overall scores higher than 6, and all 5 of those questions were in the top 10 RCT questions by overall score. Six of the top 10 selected questions focused on determining optimal antibiotic regimens for 3 common infections (pneumonia, urinary tract infection, and cellulitis). Two questions scored higher than 6 for importance but decreased below 6 after considering feasibility. These 2 questions involved antibiotic duration for children with bacteremia or meningitis and ultimately ranked 25th and 29th (eTable in Supplement 1 ).

For this consensus statement, we led a national, 3-stage modified Delphi process involving interdisciplinary, expert stakeholders, including patient-parent partners, to identify the most important and feasible RCT questions for children hospitalized with common conditions. Most of the RCT questions that we identified were pragmatic, comparing interventions in widespread use for which definitive effectiveness data are lacking. Our findings serve as an empirical foundation to guide investigators and funders in conducting impactful trials that improve outcomes for children hospitalized with common conditions.

The present research prioritization effort differs from existing prioritization studies in several fundamental ways. Some prior studies have focused on understanding condition prevalence, care variation, and costs for pediatric hospitalizations as a means to prioritize specific conditions for research. 9 , 12 , 13 Identification of condition-specific research topics or questions was outside the scope of these studies. Other prioritization studies have focused on broader (eg, all of pediatrics 6 ) or narrower (eg, chronic conditions 14 and palliative care 15 ) sets of conditions or settings that overlap with hospitalization (eg, emergency care 16 and patient safety 17 ). Nearly all existing prioritization studies, including a recent study focused on hospitalized children, 7 have produced priority topic areas (eg, What methods of communication are most effective between patients and clinicians?), as opposed to specific PICO-framed questions. Questions developed within existing prioritization studies were also not honed for a specific empirical research strategy, such as RCTs. To our knowledge, our research prioritization is unique in its focus on hospitalized children with common conditions and its development of specific PICO-framed questions designed to be readily answered in RCTs.

The questions that were prioritized in this process reflect broad goals of improving the value of care delivered to hospitalized children by avoiding unnecessary treatments. Six of the top 10 selected questions focused on determining optimal antibiotic regimens for 3 common infections (pneumonia, urinary tract infection, and cellulitis). There is wide variation in antibiotic prescribing for these infections, raising concerns for potential antibiotic overtreatment and its detrimental effects for children (antibiotic-associated adverse effects), families (stress and costs), and communities (emergence of resistant organisms). 18 , 19 A growing body of RCT literature is demonstrating that less-aggressive antibiotic regimens are safe and effective for serious infections among adults (eg, pneumonia, bacteremia, osteomyelitis, and endocarditis), but trials on this topic remain rare for children, to our knowledge. 20 , 21

To address this ambitious list of RCT questions, investigators will likely need to augment traditional RCT designs with innovative and efficient RCT approaches. Many of the RCT questions developed in this study have natural overlap and could be considered for funding mechanisms that can support addressing multiple trial questions in a single application. For example, platform trials examine multiple research questions for a single condition. 22 Given that the present work generated multiple RCT questions for each condition, platform RCTs might be an efficient design to address more than 1 of these RCT questions at once. Similarly, factorial RCT designs could be used to address multiple questions at once when understanding the synergistic effect of 2 or more interventions is key. 23 As an example, 3 of the top 6 RCT questions developed here involve children hospitalized with urinary tract infections and their antibiotic regimens. The single condition entity and similar interventions could lend themselves to a platform or factorial design. Randomized clinical trial questions developed here may also lend themselves to a high-efficiency randomized controlled (HEROIC) trial approach, which uses a dispersed enrollment strategy to efficiently conduct pragmatic RCTs. 24

The consensus statement has several important limitations. First, these RCT questions will require further refinement as the trial is designed, including additional definitions for each intervention and careful consideration of the right primary outcome. Second, our consideration of feasibility focused on trial infrastructure (the ability to recruit, administer intervention or control, and collect data). This feasibility assessment was within the scope of conference participant skills and resources. During formal trial design or preparation, an additional feasibility assessment would be completed, including human participants protection review, confirmation of adequate numbers of eligible participants at proposed study sites, formal sample size estimates, power calculations, and budget or cost estimates. These considerations will undoubtedly influence the feasibility of each RCT question. Third, conference participants were diverse in many ways but did not represent all perspectives pertinent to RCT question generation in this population. Fourth, RCT question development was organized around common conditions. Undoubtedly, there are additional important and feasible questions that are not condition based (eg, RCTs comparing processes such as transitions of care) or that are focused on less-common conditions. Fifth, our 3-stage process could have been subject to anchoring bias, in which decisions made early in the process by smaller numbers of participants are difficult to reconsider later in the process. Sixth, investigators who pursue the RCTs described in this study will still contend with pervasive impediments to RCTs for children, such as relatively modest disease prevalence, lower frequency of objective outcome measures (eg, mortality), and fewer sources of funding compared with RCTs for adult populations. For example, the 2 questions that scored higher than 6 for importance but then ultimately decreased below 6 after considering feasibility involved less-common subpopulations of hospitalized children (children with bacteremia or meningitis). For RCT questions with particularly low feasibility scores, observational study designs might be more practical.

In this consensus statement, we have identified the most important and feasible RCT questions for children hospitalized with common conditions. These conditions are responsible for more than three-fourths of pediatric hospitalizations. Answering these pressing questions with RCTs has great potential to improve care and outcomes for hospitalized children.

Accepted for Publication: March 13, 2024.

Published: May 15, 2024. doi:10.1001/jamanetworkopen.2024.11259

Open Access: This is an open access article distributed under the terms of the CC-BY License . © 2024 Coon ER et al. JAMA Network Open .

Corresponding Author: Eric R. Coon, MD, MS, Department of Pediatrics, University of Utah School of Medicine, 100 N Mario Capecchi Dr, Salt Lake City, UT 84113 ( [email protected] ).

Author Contributions: Dr Coon had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Coon, McDaniel, Paciorkowski, Jennings, Wilson, Kaiser.

Acquisition, analysis, or interpretation of data: Coon, McDaniel, Paciorkowski, Grimshaw, Frakes, Ambroggio, Auger, Cohen, Garber, Gill, Joshi, Leyenaar, McCulloh, Pantell, Sauers-Ford, Schroeder, Srivastava, Wang, Wilson, Kaiser.

Drafting of the manuscript: Coon, Frakes, Gill, Pantell.

Critical review of the manuscript for important intellectual content: Coon, McDaniel, Paciorkowski, Grimshaw, Frakes, Ambroggio, Auger, Cohen, Garber, Gill, Jennings, Joshi, Leyenaar, McCulloh, Sauers-Ford, Schroeder, Srivastava, Wang, Wilson, Kaiser.

Statistical analysis: Coon.

Obtained funding: Coon, Wilson, Kaiser.

Administrative, technical, or material support: Grimshaw, Ambroggio, Gill, McCulloh, Wilson, Kaiser.

Supervision: Wilson, Kaiser.

Conflict of Interest Disclosures: Dr Ambroggio reported receivng grants from Pfizer Inc outside the submitted work. Dr Cohen reported being a member of the Committee to Evaluate Drugs, which provides advice to the Ministry of Health on Ontario’s Public Drug Policy. Dr Gill reported receiving grants from Physicians’ Services Incorporated Foundation, Canadian Institutes of Health Research (CIHR), and Hospital for Sick Children outside the submitted work. Dr McCulloh reported receiving grants from the National Institutes of Health from the Office of the Director during the conduct of the study and grants from Merck Inc outside the submitted work. Dr Schroeder reported receiving grants from the Patient-Centered Outcomes Research Institute outside the submitted work. Dr Srivastava reported being a physician founder of the IPASS Patient Safety Institute, and his equity is owned by his employer, Intermountain Health, outside the submitted work; receiving grants from the Patient-Centered Outcomes Research Institute, National Institutes of Health, and Centers for Disease Control and Prevention; and receiving monetary awards, honoraria, and travel reimbursement from multiple academic and professional organizations for teaching and consulting on quality of care and spreading evidence-based best practices in health systems and pediatric hospital medicine. No other disclosures were reported.

Funding/Support: This study was financially supported by the Agency for Healthcare Research and Quality, US Department of Health and Human Services and the Division of Pediatric Hospital Medicine, the University of California San Francisco.

Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Group Information: The members of the RCT conference series group are listed in Supplement 2 .

Disclaimer: The contents are those of the authors. They may not reflect the policies of the US Department of Health and Human Services or the US government.

Data Sharing Statement: See Supplement 3 .

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Seizures in Neonates: Diagnosis and Management in the Emergency Department

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Seizures in neonates can be difficult to diagnose because they often present with subtle signs and symptoms. Patient stabilization, seizure cessation, and determination of the etiology are key aspects of emergency department management. This issue reviews common presentations and causes of neonatal seizures, provides recommendations for management in the emergency department, and evaluates existing evidence regarding antiepileptic medications for treatment of neonatal seizures. You will learn:

Common presentations of neonatal seizures, and how to distinguish those from benign mimics of seizures, various etiologies for neonatal seizures, and which are the most common, how the timing of presentation can help determine the cause of the seizure, key components of the physical examination that should be conducted for neonates with seizure activity, what types of diagnostic studies are indicated, and which are highest yield, which antiepileptic drugs have the most evidence supporting their use in neonates, as well as which are recommended as first-line, second-line, and third-line choices, recommendations for non–antiepileptic drug management of neonatal seizures, which neonates should be admitted, when admission to a pediatric or neonatal intensive care unit is warranted, and under which circumstances a neonate can be discharged, case presentations, introduction, critical appraisal of the literature, infectious etiologies.

• Vascular Etiologies
• Inborn Errors of Metabolism
• Other Etiologies
• Timeline for Seizure Onset
• Differential Diagnosis
• Prehospital Care
• Initial Stabilization
• Physical Examination
• Laboratory Studies
• Imaging Studies
• Electroencephalography
• Phenobarbital
• Phenytoin/Fosphenytoin
• Levetiracetam
• Benzodiazepines
• Other Antiepileptic Drugs
• Non–Antiepileptic-Drug Management
• Premature Neonates
• Patients With Recurrent Brief Resolved Unexplained Events
• Patients Who Have Not Had Standard Prenatal Care/Patients With Risk of Exposure to Infectious Agents
• Patients Born Outside a Medical Facility
• Medication Choices
• Amplitude-Integrated Electroencephalography
• Genetic Testing
• Disposition
• Time- and Cost-Effective Strategies

Risk Management Pitfalls for Neonatal Seizures

• Case Conclusions
• Clinical Pathway for Management of Neonatal Seizures
• Table 1. Risk Factors for Neonatal Seizures
• Table 2. Seizure Etiologies
• Table 3. Antiepileptic Drugs
• Table 4. Medications to Correct Metabolic Derangements
• Figure 1. Seizure Onset Timeline: Seizure Etiology By Postnatal Age

Neonatal seizures are associated with high morbidity and mortality, but they can be difficult to diagnose because they often present with subtle signs and symptoms. Initial management goals in the emergency department include patient stabilization, seizure cessation, and determination of the etiology; identification of life-threatening treatable causes of the seizures should be prioritized. Further management depends on the history and physical examination findings, laboratory testing results, and imaging studies. This issue reviews common presentations and causes of neonatal seizures, considerations for emergency department management, and the evidence regarding antiepileptic medications for neonates.

An EMS team brings in a 5-day-old boy with a history of a rhythmic, left-arm-shaking episode at home. The parents tell you the pregnancy was normal and the birth was a full-term, normal spontaneous vaginal delivery. The baby had been doing well until yesterday, when he started eating less and not waking up for feeds. The baby has low tone with a tense anterior fontanelle, and his temperature is 35.8˚C (96.4˚F). What workup is warranted at this time?

A mother brings in her newborn daughter, with concern for abnormal movements. The girl was born at 34 weeks' gestation; she is now 3 weeks old. The mother says the baby will often stiffen and arch her back, and she is worried because there is a family history of epilepsy. The baby has no chronic lung disease or severe complications from prematurity. There have been no recent fevers or sick contacts. The baby has been falling off the growth curve despite high-calorie formula. She often spits up, which seems to make her uncomfortable. The mother brought in a video that captures one of the episodes. You watch the video and see 10 seconds of full-body stiffening, reddening of the face, and significant back arching. The baby has a normal neurologic examination with normal tone, reflexes, and a soft, flat anterior fontanelle. Could this be a seizure disorder? What other diagnoses are on your differential?

Your next patient is a 6-day-old full-term baby boy. His parents brought him in because he was vomiting. He has not been feeding well and is still below birth weight. He started vomiting intermittently several days ago, but now he is vomiting after every feeding. The state newborn screen has not yet resulted. While you are examining him, he starts to have repetitive blinking, followed by staring. After this, he fell asleep. A few minutes later, his right arm stiffens, and it progresses to generalized shaking. What could be causing this baby’s behavior? What kinds of medications may be required?

The incidence of seizures in children is highest in the neonatal period (defined as up to age 28 days, or 44 weeks of gestational age for premature infants). Seizures affect 3 to 5 of every 1000 children, with an increased risk among premature infants (2-3/1000 full-term neonates; 10-15/1000 preterm neonates). 1 Neonatal seizures are associated with high mortality and risk for adverse neurodevelopmental outcomes, 2,3 and often confer a poorer prognosis compared to seizures in older children. Seizure activity in this age group can be subtle, as they are typically focal seizures, and only rarely generalized, tonic-clonic seizures. Neonates who exhibit seizure-like activity often present to the emergency department (ED), especially if activity is severe. Neonatal seizures most often present in the first 2 days of life, with 80% of neonatal seizures presenting within the first week of life. 4

Most neonatal seizures are secondary in etiology, rather than representing a primary epilepsy syndrome. Because of neonates’ immature nervous systems, seizures can be difficult to diagnose, as they often present as subtle movements with a range of clinical appearances. Seizures in neonates present most commonly as subtle focal automatisms, such as lip-smacking, tongue protrusion, sucking, chewing, paddling, arm or leg bicycling, swimming, boxing, or ocular movements. 5,6 Overall, abnormal eye movements are the most common manifestation and can include deviation, repetitive blinking, or staring. 5 Seizures can also be clonic, characterized by repetitive, rhythmic, jerking movements; or tonic, with stiffness (often with extension in all extremities or extension of legs with flexion of arms), and may be focal or generalized. 5 Myoclonic seizures with isolated or nonrhythmic jerking movements can also be focal, multifocal, or generalized. 4,6,7 Status epilepticus is defined as continuous or repetitive seizure activity for more than 5 minutes, or a series of seizures between which there is no return to baseline. 5,8 High seizure burden and status epilepticus have been associated with worse outcomes. 1

Early seizure cessation is important for improved patient outcomes. However, even with prompt treatment, the overall prognosis for neonates with seizures remains poor. Diagnosis of neonatal seizures is often made definitively by electroencephalography (EEG), as both electroclinical dissociation (when seizure activity on EEG is not observable clinically) and benign mimics (events that clinically appear to be seizures without abnormal EEG activity) are both common in this age. 9 With this in mind, this issue will focus on clinical neonatal seizures, as these cases are most likely to present to the ED for evaluation and can be diagnosed clinically. The treatment of neonatal seizures depends on the etiology, but most often includes an antiepileptic drug or correction of the inciting pathology.

This issue of Pediatric Emergency Medicine Practice reviews common presentations and causes of neonatal seizures, provides recommendations for management in the ED, and evaluates existing evidence regarding antiepileptic medications for treatment of neonatal seizures.

A PubMed search was conducted for literature on neonatal seizures using the search terms: neonatal seizure[s] , infantile seizures , infant seizure , and neonate[s] and seizure[s] . The search yielded 760 initial results and was limited to infants aged < 1 month, English language or available English-language translation, and non–neonatal intensive care unit (NICU) or non–postoperative cardiac surgical studies. Abstracts were reviewed for relevance, and a total of 80 articles were identified. A review of the citations expanded the total to 110 articles, of which, 78 were chosen for inclusion.

There are limited randomized controlled trials (RCTs) evaluating neonatal seizures, with 3 RCTs focusing on treatment. 10-12 Additionally, there are 3 systematic reviews on treatment. 13-15 The existing body of evidence consists largely of retrospective studies and a few prospective studies, as well as many case reports, case series, and reviews. Many studies are limited by small sample size and inconsistent diagnostic and treatment success criteria (ie, EEG-confirmed vs clinical seizures).

The neonate is susceptible to seizures due to an imbalance of excitatory and inhibitory pathways in the immature neonatal brain. 16 Additionally, complications in the birthing process, such as trauma or hypoxia, may result in seizures. 16 Risk factors for seizures include maternal influences, perinatal factors, infant characteristics, and family history. 17,18 (See Table 1.)

There is a wide range of causes of neonatal seizures (see Table 2) , with the leading etiologies being hypoxic ischemic encephalopathy (HIE), vascular disorders, infections, and acquired metabolic derangements. 5 HIE is the most common cause of seizures and is often related to a complicated birthing process. 19

Infections cause up to 20% of neonatal seizures and may present later than other etiologies. 20 Infectious causes can range from generalized sepsis to primary neurologic infections such as meningitis, encephalitis, or meningoencephalitis. Organisms to consider include a variety of bacteria, viruses, and parasites, as outlined in Table 2 . 6,21 Herpes simplex virus (HSV) may be found in the temporal lobe and is often associated with focal seizures, although this is more common in older patients. 22 Maternal history or typical HSV lesions are often absent, as the risk of transmission is highest with the initial outbreak. Rubella can cause intracranial lesions, and toxoplasmosis and cytomegalovirus classically cause intracranial calcifications, all of which can lead to seizures. Rotavirus can cause leukoencephalopathy and repetitive seizures; a retrospective study of 32 neonates with presumed postnatal rotavirus infection showed that only 25% of patients experienced diarrhea and none had fever or rash. 21

2. “The mother said the baby was feeding normally, 3 ounces of formula every 3 hours. I didn’t think to ask about the contents or how she was preparing it.”

Hypoglycemia, hypocalcemia, and hyponatremia are easily treatable causes for neonatal seizures, so do not fail to consider these. A thorough feeding history that includes formula mixing should be obtained for all infants. Some parents water down formula to conserve powder or because they don’t know the appropriate ratio. Point-of-care glucose monitoring, as well as electrolyte levels should be obtained immediately for all neonates with seizure activity.

6. “We could not obtain IV access even though our best nurses tried, so we were not able to give medication for the seizure.”

Do not forget about alternative routes for antiepileptics and other medications if vascular access is not available. Many medications can be administered through IN, IM, or rectal routes, and intraosseous access should always be considered for a critical patient in whom IV access cannot be established. Many antibiotics can also be given IM.

7. “The described event sounded a bit suspicious, but the baby looked great on exam in the ED, so I thought maybe it was nothing serious.”

Any neonate with witnessed or current seizure activity should be admitted for monitoring. Think twice about discharging, and only do so if it is certain that the event was a benign mimic or there is comfortable, reliable follow-up in place with the primary care provider and/or neurologist, as the event may warrant an EEG in the near future. Remember that electroclinical dissociation is common, and seizures in the neonatal population are always worrisome.

Tables and Figures

Evidence-based medicine requires a critical appraisal of the literature based upon study methodology and number of subjects. Not all references are equally robust. The findings of a large, prospective, randomized, and blinded trial should carry more weight than a case report.

To help the reader judge the strength of each reference, pertinent information about the study is included in bold type following the reference, where available. In addition, the most informative references cited in this paper, as determined by the author, are  highlighted .

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Publication Information

Melissa L. Langhan, MD, MHS, FAAP; Brielle Stanton, MD

Peer Reviewed By

Nicole Gerber, MD; Quyen Luc, MD

Publication Date

June 1, 2020

CME Expiration Date

Pub med id: 32470245.

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Allie Hurst named medical director for Med Flight Pediatric Critical Care Transport

UW Health recently announced the appointment of Dr. Allie Hurst as the medical director for UW Health Med Flight Pediatric Critical Care Transport starting May 1, 2024. In her new role, Dr. Hurst will partner Med Flight’s physician medical directors for adult and neonatal patients, as well as with nursing and operational leadership, to provide cutting-edge and conscientious medical direction for UW Health’s exceptional neonatal and pediatric critical transport team.

Dr. Hurst joined the Division of Pediatric Emergency Medicine in 2020 as the first UW Health Med Flight fellow also fellowship-trained in pediatric emergency medicine. After fellowship, she joined the Departments of Emergency Medicine and Pediatrics as an assistant professor – clinical health sciences. Along with her interest in transport medicine, Dr. Hurst undertakes education and research roles in the Department of Emergency Medicine. Her research focuses on adolescent health, specifically child trafficking and substance abuse including operationalizing screening tools in our emergency department for the identification of human trafficking.

Dr. Hurst completed her pediatrics residency at the Ann & Robert H. Lurie Children’s Hospital of Chicago and pediatric emergency medicine fellowship at the University of Colorado. She is also the medical director for the American Family Children’s Hospital pediatric emergency department and has excelled in leading the team through multiple quality improvement projects.

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