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BACKGROUND: Based on the most recently published recommendations from the Committee on the Fetus and Newborn (COFN), three approaches currently exist for the use of risk factors to identify infants who are at increased risk of early-onset sepsis (EOS). Categorical risk factor assessments recommend laboratory testing and empiric antibiotic therapy for all infants born to mothers with a clinical diagnosis of chorioamnionitis. Risk assessments based on clinical condition recommend frequent examinations and close vital sign monitoring for infants born to mothers with chorioamnionitis. The Kaiser Permanente EOS risk calculator (SRC) is an example of the third approach, multivariate risk assessments. The aim of our study was to compare the three risk stratification approaches recommended by the COFN for management of chorioamnionitis-exposed infants. METHODS: Retrospective study of 1,521 infants born ≥35 weeks to mothers with chorioamnionitis. Management recommendations of the SRC were compared to the recommendations of categorical risk assessment and risk assessment based on clinical condition (CCA). RESULTS: Hypothetical application of SRC and CCA resulted in 79.6% and 76.8–85.1% respectively fewer infants allocated empiric antibiotic therapy. While CCA recommended enhanced observation for all chorioamnionitis-exposed infants, SRC recommended routine care without enhanced observation in 44.3% infants. For the six infants (0.39%) with EOS, SRC and CCA recommended empiric antibiotics only for three symptomatic infants. CONCLUSION: The SRC and CCA can reduce antibiotic use but potentially delay antibiotic treatment. The SRC does not recommend enhanced observation with frequent and prolonged vital signs for >44% of chorioamnionitis-exposed infants.

OBJECTIVE To assess if infants with neonatal abstinence syndrome (NAS) are smaller at birth and have decreased growth parameters between birth and discharge from the neonatal intensive care unit (NICU). METHODS Retrospective data analysis of term/late-preterm neonates with NAS at a single-center NICU between September 2006 and May 2018. Growth parameters (weight, length, HC) were measured at birth and discharge. Z scores and percentiles were calculated using WHO standard growth curves. RESULTS A total of 864 infants ≥35 weeks were admitted for NAS. At birth, median percentiles were weight 30%, HC 23%, and length 37%; these decreased significantly (p

OBJECTIVE: To examine whether the coronavirus disease 2019 (COVID-19) pandemic altered risk of adverse pregnancy-related outcomes and whether there were differences by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection status among pregnant women. METHODS: In this retrospective cohort study using Epic's Cosmos research platform, women who delivered during the pandemic (March-December 2020) were compared with those who delivered prepandemic (matched months 2017-2019). Within the pandemic epoch, those who tested positive for SARS-CoV-2 infection were compared with those with negative test results or no SARS-CoV-2 diagnosis. Comparisons were performed using standardized differences, with a value greater than 0.1 indicating meaningful differences between groups. RESULTS: Among 838,489 women (225,225 who delivered during the pandemic), baseline characteristics were similar between epochs. There were no significant differences in adverse pregnancy outcomes between epochs (standardized difference

To evaluate the utility of screening all extremely preterm infants for retinopathy of prematurity (ROP) at 4 weeks chronologic age, which is earlier than recommended by the 2018 AAP guidelines. Retrospective analysis of infants

Background The antibiotic use rate (AUR) has emerged as a potential metric for neonatal antibiotic use, but reported center-level AURs are limited by differences in case mix. The objective of this study was to identify patient characteristics associated with AUR among a large cohort of preterm infants. Methods Retrospective observational study using the Optum Neonatal Database, including infants born from January 1, 2010 through November 30, 2016 with gestational age 23–34 weeks admitted to neonatal units across the United States. Exposures were patient-level characteristics including length of stay, gestational age, sex, race/ethnicity, bacterial sepsis, necrotizing enterocolitis, and survival status. The primary outcome was AUR, defined as days with ≥ 1 systemic antibiotic administered divided by length of stay. Descriptive statistics, univariable comparative analyses, and generalized linear models were utilized. Results Of 17 910 eligible infants, 17 836 infants (99.6%) from 1090 centers were included. Median gestation was 32.9 (interquartile range [IQR], 30.3–34) weeks. Median length of stay was 25 (IQR, 15–46) days and varied by gestation. Overall median AUR was 0.13 (IQR, 0–0.26) and decreased over time. Gestational age, sex, and race/ethnicity were independently associated with AUR (P Conclusions Neonatal AURs are influenced by patient-level characteristics besides infection and survival status, including gestational age, sex, and race/ethnicity. Neonatal antibiotic use metrics that account for patient-level characteristics as well as morbidity case mix may allow for more accurate comparisons and better inform neonatal antibiotic stewardship efforts.

The Baby Friendly Hospital initiative (BFHI) is a global initiative of the World Health Organization developed in 1991 to promote and support successful breastfeeding. It has led to increased rates of exclusive breastfeeding. Exclusive breastfeeding may increase risk for hypoglycemia, hyperbilirubinemia, and dehydration requiring higher level of neonatal care.To determine if there was a change in admissions to the Neonatal Intensive Care Unit (NICU) from the newborn nursery after the adoption of BFHI in a large urban hospital.This is a retrospective analysis of all neonates admitted to the NICU from the newborn nursery between January 2007 and December 2016 at Thomas Jefferson University Hospital, in Philadelphia, PA, USA. Demographics, clinical characteristics and primary diagnosis for admission were compared between those admitted before (January 2007 to December 2011) and after (January 2012 to December 2016) the initiation of BFHI.A total of 20,124 infants were born and 3,684 infants (18.3%) were admitted to NICU. 570 infants (2.8% of live birth) were admitted to the NICU from the newborn nursery, 282 (49.5%) were born before and 288 (50.5%) born after BFHI. There was no significant difference in the number of infants admitted from the newborn nursery either as a percentage of total deliveries (2.8 versus 2.9%,The BFHI has not led to a significant change in the number of infants admitted to NICU from the newborn nursery or reasons for their admissions. However, since its adoption, there has been an increase in the use of IV fluids for treatment of hypoglycemia. These findings suggest a role for additional treatments other than formula to prevent IV fluid use, such as glucose gel. Change in NICU guidelines for the management of possible sepsis and NAS may have impacted the duration of hospitalization in infants born after BFHI.

To determine if prolonging gavage feedings in infants for ≥60 min is associated with decreased gastroesophageal reflux (GER) compared with bolus feeding using multiple-channel intraluminal impedance with pH probe (MII-pH). Retrospective analysis of infants who underwent MII-pH between October 2009 and July 2018 and received gavage feedings. Infants were divided into two groups: bolus (

OBJECTIVES To determine if birth hospitalization length of stay (LOS) and infant rehospitalization changed during the coronavirus disease 2019 (COVID-19) era among healthy, term infants. METHODS Retrospective cohort study using Epic’s Cosmos data from 35 health systems of term infants discharged ≤5 days of birth. Short birth hospitalization LOS (vaginal birth RESULTS Among 202 385 infants (57 110 from the COVID-19 era), short birth hospitalization LOS increased from 28.5% to 43.0% for all births (vaginal: 25.6% to 39.3%, cesarean: 40.1% to 61.0%) during the pandemic and persisted after multivariable adjustment (all: aOR 2.30, 95% confidence interval [CI] 2.25–2.36; vaginal: aOR 2.12, 95% CI 2.06–2.18; cesarean: aOR 3.01, 95% CI 2.87–3.15). Despite shorter LOS, infant rehospitalizations decreased slightly during the pandemic (1.2% to 1.1%); results were similar in adjusted analysis (all: aOR 0.83, 95% CI 0.76–0.92; vaginal: aOR 0.82, 95% CI 0.74–0.91; cesarean: aOR 0.87, 95% CI 0.69–1.10). There was no change in the proportion of rehospitalization diagnoses between eras. CONCLUSIONS Short infant LOS was 51% more common in the COVID-19 era, yet infant rehospitalization within a week did not increase. This natural experiment suggests shorter birth hospitalization LOS among family- and clinician-selected, healthy term infants may be safe with respect to infant rehospitalization, although examination of additional outcomes is needed.

BACKGROUND: There are three different approaches set forth by the Committee on the Fetus and Newborn (COFN) for managing asymptomatic neonates born to mothers with inadequate intrapartum antibiotic prophylaxis (IAP) for early-onset Group B Strep (GBS) infection. The first approach is that of categorical risk factor assessments, and recommends that asymptomatic infants born to afebrile mothers with inadequate IAP for GBS be monitored with clinical observation for 36–48 hours. The second approach recommends serial physical examinations and vital signs for 36–48 hours to closely monitor changes in clinical condition for all patients. The Kaiser Permanente EOS risk calculator (SRC) is an example of the third approach, a multivariate risk assessment, and it takes into consideration several perinatal risk factors. This multivariate risk assessment then provides recommendations for reassessment and management based on presume risk of the infant developing or having Early Onset Sepsis (EOS). The aim of our study was to compare these three recently published recommendations from the COFN for the management of asymptomatic neonates born to afebrile mothers with inadequate IAP for GBS. STUDY DESIGN: This is a retrospective study of asymptomatic neonates with gestational age ≥35 weeks born to afebrile mothers with indicated inadequate IAP for GBS between April 2017 and July 2020. Management recommendations of the SRC were compared to the recommendations of categorical risk assessment and risk assessment based on clinical condition. RESULTS: A total of 7,396 infants were born during the study period, 394 (5.3%. to mothers with inadequate IAP. Recommendations for these infants according to both the categorical risk factor guideline and the clinical condition guideline include extended, close observation. However, the SRC recommended routine newborn care for 99.7%.f these infants. None of the infants developed EOS. CONCLUSION: The SRC recommend routine neonatal care without enhanced and prolonged observation for nearly all asymptomatic infants born to afebrile mothers with inadequate IAP. As none of the infants in this cohort had EOS, further studies in a larger cohort are needed to establish the safety of SRC in neonates born to mothers with inadequate IAP.

Objective To validate the recently modified Kaiser Permanente early-onset sepsis (EOS) calculator with a higher baseline incidence in chorioamnionitis exposed neonates. Study design This is a retrospective study of chorioamnionitis-exposed neonates born at ≥35 weeks of gestation with a known EOS incidence of 4.3/1000. The risk and management categories were calculated using the calculator with an incidence of 4/1000. The results were compared with a previous analysis of the same cohort that used an EOS incidence of 0.5/1000. Results In our sample, the EOS calculator recommends at least a blood culture in 834 of 896 (93.1%) and empiric antibiotics in 533 of 896 (59.5%) chorioamnionitis-exposed neonates when using an EOS incidence of 4/1000. This captures 5 of 5 neonates (100%) with EOS. When using a baseline EOS incidence of 0.5/1000, the calculator recommends at least a blood culture in only 289 of 896 (32.2%) and empiric antibiotics in only 209 of 896 (23.3%) neonates, but fails to recommend empiric antibiotics in 2 of 5 neonates with EOS (40%). Conclusions When using an EOS risk of 4 of 1000 in infants exposed to mothers with chorioamnionitis, the EOS calculator has the ability to capture an increased number of neonates with culture-positive EOS. However, this change also leads to nearly a 3-fold increase in the use of empiric antibiotics and an evaluation with blood culture in almost all infants born to mothers with chorioamnionitis.

Objective The objective of this study is to assess whether infants with neonatal abstinence syndrome (NAS), who receive maternal breast milk (BM), have shorter pharmacological treatment durations and lengths of stay compared with formula-fed infants. Study design Retrospective data analysis from Optum Neonatal Database for infants born between 1 January 2010 and 21 November 2016, who received treatment for NAS. Clinical characteristics and outcomes were compared between infants who received any amount of BM and those exclusively formula-fed. Result Infants (1738) were analyzed. Median length of pharmacological treatment was significantly lower in infants who received any BM (14 days) compared with "no BM" group (17 days, p = 0.04). Similarly, median length of hospitalization was significantly reduced in "any BM" group (19 days vs. 20 days), which remained significant after adjustment for confounders (p = 0.01). There was no difference in hospital re-admission rates. Conclusion Feeding any BM to infants with NAS was associated with both decreased lengths of pharmacological treatment and hospital stay compared with exclusively formula-fed infants.

Objective The aim of the study is to assess the correlation between maternal methadone dose and severity of neonatal abstinence syndrome (NAS) in infants that required pharmacological treatment for NAS. Study Design This is a retrospective analysis of 574 infants ≥35 weeks' gestation exposed to methadone in utero, born between August 2006 and May 2018, and who required pharmacological therapy for NAS. Indicators of NAS severity (duration of morphine treatment, maximum morphine dose, use of phenobarbital, and length of hospitalization) were compared between infants exposed to high (≥200 mg), intermediate (100–199 mg), and low doses ( Results Median (interquartile range) duration of medical treatment with morphine was higher in infants exposed to higher doses of methadone (low dose 23 [14–37] days, intermediate dose 31 [18–45] days, and high dose 35 [20–48] days, p Conclusion Infants exposed to higher methadone doses displayed more severe NAS, as indicated by longer durations of treatment, higher maximum morphine dose, longer duration of hospitalization, and increased likelihood of phenobarbital use. Key Points

To determine the prevalence of low mean corpuscular volume (MCV) in newborn infants admitted to the neonatal intensive care unit and to assess low MCV as a diagnostic test for alpha thalassemia.Retrospective analysis of all infants admitted to the neonatal intensive care unit between January 2010 and October 2018 for which a complete blood count was performed during the first 3 postnatal days. Infants with a low MCV were compared with those with a normal MCV. Infants with positive hemoglobin Bart (Hb Bart) were compared with those withnegative Hb Bart. Low MCV was also evaluated as a diagnostic test for alpha thalassemia.A total of 3851 infants (1386 preterm, 2465 term) met the inclusion criteria and 853 (22.2%) had a low MCV. A low MCV was more common in term (25%) compared with preterm infants (17.1%, P .001). Hb Bart positive newborn screening was identified in 133 infants (3.5%). Hb Bart was positive in 11.1% of infants with low MCV compared with 1.3% with normal MCV (P .001). The sensitivity, specificity, positive predictive value, and negative predictive value of low MCV for the diagnosis of alpha thalassemia were 71.4%, 79.6%, 11.3%, and 98.7%, respectively.As Hb Bart positive newborn screens were seen in only 11.1% of infants with microcytosis, further diagnostic investigation may be warranted in individual infants. Further research to correlate microcytosis with iron status in infants and mothers is needed as well as studies using DNA analysis for the evaluation of alpha thalassemia variants.

Background: Histological chorioamnionitis (HCA) is an infection/inflammation of fetal membranes and complicates 5.2-28.5% of all live births. Exposure to HCA can have long-term consequences including abnormal neurodevelopment and an increased risk for allergic disorders and asthma later in childhood. HCA may incite epigenetic changes, which have the potential to modulate both the immune and neurological systems as well as increase the risk of related disorders later in life. However, there is limited data on the impact of HCA on epigenetics, in particular DNA methylation, and changes to immune and neurological systems in full-term human neonates. Objective: To determine differential DNA methylation in cord blood mononuclear leukocytes from neonates exposed to HCA. Methods: Cord blood was collected from 10 term neonates (5 with HCA and 5 controls without HCA) and mononuclear leukocytes were isolated. Genome-wide DNA methylation screening was performed on Genomic DNA extracted from mononuclear leukocytes. Results: Mononuclear leukocytes from cord blood of HCA-exposed neonates showed differential DNA methylation of 68 probe sets compared to the control group (44 hypermethylated, 24 hypomethylated) with a p ≤ 0.0001. Several genes involved in immune modulation and nervous system development were found to be differentially methylated. Important canonical pathways as revealed by Ingenuity Pathway Analysis (IPA) were CREB Signaling in Neurons, FcγRIIB Signaling in B Lymphocytes, Cell Cycle: G1/S Checkpoint Regulation, Interleukin-1, 2, 3, 6, 8, 10, 17, and 17A signaling, p53 signaling, dopamine degradation, and serotonin degradation. The diseases and disorders picked up by IPA were nervous system development and function, neurological disease, respiratory disease, immune cell trafficking, inflammatory response, and immunological disease. Conclusions: HCA induces differential DNA methylation in cord blood mononuclear leukocytes. The differentially methylated genes may contribute to inflammatory, immunological and neurodevelopmental disorders in neonates exposed to HCA.

To evaluate the utility of screening all extremely preterm infants for retinopathy of prematurity (ROP) at 4 weeks chronologic age, which is earlier than recommended by the 2018 AAP guidelines.Retrospective analysis of infants27 weeks gestation from two tertiary NICUs between 2006 and 2018 who survived until first eye examination.550 infants (gestational age 25.1 ± 1.2 weeks and birth weight 758 ± 323 g) had 1310 examinations performed by 32 weeks postmenstrual age (PMA), and 676 (51.6%) of these were prior to 31 weeks PMA. No examinations in infants prior to 31 weeks PMA met the criteria for laser therapy. Of 87/550 infants (15.8%) who required laser therapy, none did so prior to 32 weeks PMA.No infants born27 weeks gestation were found to have severe ROP prior to 31 weeks PMA, supporting the most recent AAP recommendation of initiating ROP screening at 31 weeks PMA for extremely preterm infants.

Objectives: To determine the prevalence of dehydration fever in infants admitted to the Neonatal Intensive Care Unit (NICU) from the well newborn nursery with fever in the first days of life.Study ...

ObjectiveTo characterise the excess risk for death, grade 3–4 intraventricular haemorrhage (IVH), bronchopulmonary dysplasia (BPD) and stage 3–5 retinopathy of prematurity independently associated with birth small for gestational age (SGA) among very preterm infants, stratified by completed weeks of gestation.MethodsRetrospective cohort study using the Optum Neonatal Database. Study infants were born ResultsOf 6708 infants sampled from 717 US hospitals, 743 (11.1%) were SGA. SGA compared with non-SGA infants experienced higher unadjusted rates of each study outcome except grade 3–4 IVH among survivors. The excess risk independently associated with SGA birth varied by outcome and gestational age. The highest aRD for death (0.27; 95% CI 0.13 to 0.40) occurred among infants born at 24 weeks gestation and declined as gestational age increased. In contrast, the peak aRDs for BPD among survivors (0.32; 95% CI 0.20 to 0.44) and the composites of death or BPD (0.35; 95% CI 0.24 to 0.46) and death or major morbidity (0.35; 95% CI 0.24 to 0.45) occurred at 27 weeks gestation. The risk-adjusted probability of dying or developing one or more of the evaluated morbidities among SGA infants was similar to that of non-SGA infants born approximately 2–3 weeks less mature.ConclusionThe excess risk for neonatal morbidity and mortality associated with being born SGA varies by adverse outcome and gestational age.

To determine if prolonging gavage feedings in infants for ≥60 min is associated with decreased gastroesophageal reflux (GER) compared with bolus feeding using multiple-channel intraluminal impedance with pH probe (MII-pH).Retrospective analysis of infants who underwent MII-pH between October 2009 and July 2018 and received gavage feedings. Infants were divided into two groups: bolus (30 min) or prolonged (≥60 min). Symptoms, number of reflux events and percent time pH 4 was compared.Fifty-eight infants underwent evaluation. Thirty-one (54%) received bolus gavage feedings and 27 (46%) received prolonged feedings. Groups differed in postmenstrual age. Total reflux episodes were significantly lower with prolonged feeding (median 19 vs. 28 episodes, p = 0.015), with no difference in acid exposure time. There was no significant difference in GER symptoms between the two groups.Prolongation of gavage feedings was associated with decreased total numbers of GER events without reduction in GER symptoms.

To determine differences in severe intraventricular hemorrhage (IVH) between very-low-birth-weight (≤1500 g, VLBW) infants born to mothers with and without hypertensive disorders (HD). Retrospective analysis from the Optum Neonatal Database. The primary outcome of interest was severe IVH (grade 3 or 4). Secondary outcomes included other neonatal morbidities, mortality, and length of hospitalization. Outcomes were compared between VLBW infants born to mothers with and without HD. A total of 5456 infants met inclusion criteria. After multivariable regression analysis, risks of severe IVH and bronchopulmonary dysplasia (BPD) were lower ([OR 0.42, 95% CI 0.33–0.89, p = 0.01] and [OR 0.75, 95% CI 0.58–0.97, p = 0.03], respectively) and median length of hospitalization was decreased in the HD group (49 versus 61 days, p

Objective To determine the short-term outcomes (abnormal brain magnetic resonance imaging [MRI]/death) in infants born with a 10-minute Apgar score of 0 who received therapeutic hypothermia and compare them with infants with higher scores. Study Design This is a retrospective review of 293 neonates (gestational age ≥ 35 weeks) born between November 2006 and October 2015 admitted with hypoxic-ischemic encephalopathy who received therapeutic hypothermia. Results of brain MRIs were assessed by the basal ganglia/watershed scoring system. Short-term outcomes were compared between infants with Apgar scores of 0, 1 to 4, and ≥5 at 10 minutes. Results Eight of 17 infants (47%) with an Apgar of 0 at 10 minutes survived, having 4 (24%) without abnormalities on the brain MRI and 7 (41%) without severe abnormalities. There was no significant difference in the combined outcomes of “death/abnormal MRI” and “death/severe abnormalities on the MRI” between infants with Apgar scores of 0 and 1 to 4. Follow-up data were available for six of eight surviving infants, and none had moderate or severe neurodevelopmental impairment. Conclusion In the cooling era, 47% of infants with no audible heart rate at 10 minutes and who were admitted to the neonatal intensive care unit survived; 24% without abnormalities on the brain MRI and 41% without severe abnormalities.

Objective To characterize the independent association between antibiotic exposure in the first week of life and the risk of bronchopulmonary dysplasia (BPD) or death among very preterm infants without culture-confirmed sepsis. Methods Retrospective cohort study using the Optum Neonatal Database. Infants without culture-confirmed sepsis born less than 1500g and less than 32 weeks gestation between 1/2010 and 11/2016 were included. The independent association between antibiotic therapy during the first week of life and BPD or death prior to 36 weeks postmenstrual age (PMA) was assessed by multivariable logistic regression. Results Of 4950 infants, 3946 (79.7%) received antibiotics during the first week of life. Rates of BPD or death (41.5% vs. 31.1%, p

OBJECTIVE: To characterize the epidemiology of Car Seat Tolerance Screening (CSTS) failure and the association between test failure and all-cause 30-day post-discharge mortality or hospital readmission in a large, multicenter cohort of preterm infants receiving neonatal intensive care. STUDY DESIGN: Retrospective cohort study using the prospectively collected Optum Neonatal Database. Study infants were born

BackgroundCurrent pharmacologic treatment of the neonatal abstinence syndrome with morphine is associated with a lengthy duration of therapy and hospitalization. Buprenorphine may be more effective than morphine for this indication. MethodsIn this single-site, double-blind, double-dummy clinical trial, we randomly assigned 63 term infants (≥37 weeks of gestation) who had been exposed to opioids in utero and who had signs of the neonatal abstinence syndrome to receive either sublingual buprenorphine or oral morphine. Infants with symptoms that were not controlled with the maximum dose of opioid were treated with adjunctive phenobarbital. The primary end point was the duration of treatment for symptoms of neonatal opioid withdrawal. Secondary clinical end points were the length of hospital stay, the percentage of infants who required supplemental treatment with phenobarbital, and safety. ResultsThe median duration of treatment was significantly shorter with buprenorphine than with morphine (15 days vs. 28 d...

To determine if an early commencement of caffeine is associated with improved survival without bronchopulmonary dysplasia (BPD) in preterm infants.Retrospective data analysis from the Alere Neonatal Database for infants weighing ≤1250 g, and treated with caffeine within the first 10 days of life. The neonatal outcomes were compared between the infants who received early caffeine (0-2 days) with the infants who received delayed caffeine (3-10 days).A total of 2951 infants met the inclusion criteria (early caffeine 1986, late caffeine 965). The early use of caffeine was associated with reduction in BPD (OR 0.69, 95% CI 0.58-0.82, p 0.001) and BPD or death (OR 0.77, 95% CI 0.63-0.94, p = 0.01). Other respiratory outcomes also improved with the early commencement of caffeine. The frequency of severe intraventricular hemorrhage and patent ductus arteriosus was lower and the length of hospitalization was shorter in infants receiving early caffeine therapy. However, early use of caffeine was associated with an increase in the risk of nectrotizing enterocolits (NEC) (OR 1.41, 95% CI 1.04-1.91, p = 0.027).Early commencement of caffeine was associated with improvement in survival without BPD in preterm infants. The risk of NEC with early caffeine use requires further investigation.

BackgroundPediatric patients seek timely access to subspecialty care within a complex delivery system while facing barriers: distance, economics, and clinician shortages.AimWe examined stakeholder perceptions about solutions to the access challenge. We engaged over 300 referring primary care pediatricians in the evaluation of Access Clinics at an academic children’s hospital.MethodsUsing an anonymous online survey, we asked pediatricians about their and their patients’ experiences and analyzed factors that may influence referrals.FindingsReferring pediatricians reported satisfaction; they provided feedback about their patients’ experiences, physician communication, and referral influences. Distance from the Access Clinic does not correlate with differences in referral volume; living in areas with higher child populations and higher median income is associated with more referrals. Referring pediatricians have strong opinions about referrals, are attuned to patient experiences, and desire bi-directional communication. Multiple factors influence referral to and acceptance of Access Clinics, but external influences have less impact than expected.

Objective The objective of this study was to determine differences in the incidence of bronchopulmonary dysplasia (BPD) or death in very low-birth-weight (VLBW) infants managed successfully on continuous positive airway pressure (CPAP) versus mechanical ventilation on the first day of life (DOL). Study Design This is a retrospective analysis of the Alere neonatal database for infants born between January 2009 and December 2014, weighing ≤ 1,500 g. Baseline demographics, clinical characteristics, and outcomes were compared between the two groups. Multivariable regression analysis was performed to control the variables that differ in bivariate analysis. Results In this study, 4,629 infants (birth weight 1,034 ± 290 g, gestational age 28.1 ± 2.5 weeks) met the inclusion criteria. The successful use of early CPAP was associated with a significant reduction in BPD or death (p 0.001), as well as days to room air, decreased oxygen use at discharge, lower risk for severe intraventricular hemorrhage, and patent ductus arteriosus requiring surgical ligation (p 0.001 for all outcomes). Conclusion Successful use of early CPAP on the first DOL in VLBW infants is associated with a reduced risk of BPD or death.

To determine differences in the incidence of bronchopulmonary dysplasia (BPD) or death in extremely low birth weight infants managed on high flow nasal cannula (HFNC) vs continuous positive airway pressure (CPAP).This is a retrospective data analysis from the Alere Neonatal Database for infants born between January 2008 and July 2013, weighing ≤1000 g at birth, and received HFNC or CPAP. Baseline demographics, clinical characteristics, and neonatal outcomes were compared between the infants who received CPAP and HFNC, or HFNC ± CPAP. Multivariable regression analysis was performed to control for the variables that differ in bivariate analysis.A total of 2487 infants met the inclusion criteria (941 CPAP group, 333 HFNC group, and 1546 HFNC ± CPAP group). The primary outcome of BPD or death was significantly higher in the HFNC group (56.8%) compared with the CPAP group (50.4%, P .05). Similarly, adjusted odds of developing BPD or death was greater in the HFNC ± CPAP group compared with the CPAP group (OR 1.085, 95% CI 1.035-1.137, P = .001). The number of ventilator days, postnatal steroid use, days to room air, days to initiate or reach full oral feeds, and length of hospitalization were significantly higher in the HFNC and HFNC ± CPAP groups compared with the CPAP group.In this retrospective study, use of HFNC in extremely low birth weight infants is associated with a higher risk of death or BPD, increased respiratory morbidities, delayed oral feeding, and prolonged hospitalization. A large clinical trial is needed to evaluate long-term safety and efficacy of HFNC in preterm infants.

OBJECTIVESReintubation and subsequent mechanical ventilation (MV) in preterm infants after surfactant replacement therapy are associated with excess morbidity and mortality and likely increase in-hospital costs. Specific surfactant therapy selection for prevention of respiratory distress syndrome (RDS) in preterm infants receiving conventional MV may impact not only clinical outcomes but also pharmacoeconomic outcomes.METHODSWe conducted a pharmacoeconomic analysis of the impact of surfactant selection and reintubation and subsequent MV of preterm infants on health care resource utilization. Rates of reintubation and duration of MV after reintubation were determined from 1546 preterm infants enrolled in two surfactant trials comparing lucinactant to beractant and poractant alfa. Hospital costs were obtained from a 2010 US database from 1564 preterm infants with RDS, with a direct cost of $2637 per day for MV in the neonatal intensive care unit. Cost of reintubation by study and treatment was estimated as the incidence of reintubation multiplied by days on MV therapy after reintubation multiplied by cost per day for direct MV costs, standardized per 100 surfactant-treated infants.RESULTSThere were no differences between studies or treatment groups in the overall extubation rate. Average MV duration following reintubation was similar between groups in both trials; however, reintubation rates were significantly lower (pCONCLUSIONSIn this analysis, higher reintubation rates following successful extubation in preterm infants receiving animal-derived surfactant preparations significantly increased estimated in-hospital costs, primarily due to excess costs associated with MV. This analysis suggests that surfactant selection may have a significant pharmacoeconomic impact on cost of patient care. Additional cost assessment of potential reduction in reintubation-associated morbidity is warranted.

BACKGROUND: The wide need for analgesia, anesthesia, and sedation in children and the lack of pediatric labeling leads to widespread off-label use of medications for pain and sedation in children. Any attempt to address the lack of labeling will require national estimates of the numbers of children using each medication, their ages, and other factors, to understand the overall use of these medications. We describe use of analgesics, anesthetics, and sedatives in pediatric inpatients by result of conducting a statistical analysis of medication data from >800,000 pediatric hospitalizations in the United States. The purpose was to provide national estimates for the percentage of hospitalized children receiving specific analgesics, anesthetics, and sedatives and their use by age group. METHODS: Data from the Premier Database, the largest hospital-based, service-level comparative database in the country, were used. We identified all uses of a given medication, selected the first use for each child, and calculated the prevalence of use of specific medications among hospitalized children in 2008 as the number of hospitalizations in which the drug was used per 100 hospitalizations. Dose and number of doses were not considered in these analyses. RESULTS: The dataset contained records for 877,201 hospitalizations of children younger than 18 years of age at the time of admission. Thirty-three medications and an additional 11 combinations were administered in this population, including nonsteroidal antiinflammatory drugs, local and regional anesthetics, opioids, benzodiazepines, sedative-hypnotics, barbiturates, and others. The 10 most frequently administered analgesic, anesthetic, or sedative medications used in this population were acetaminophen (14.7%), lidocaine (11.0%), fentanyl (6.6%), ibuprofen (6.3%), morphine (6.2%), midazolam (4.5%), propofol (4.1%), lidocaine/prilocaine (2.5%), hydrocodone/acetaminophen (2.1%), and acetaminophen/codeine (2.0%). Use changed with age, and the direction of change (increases and decreases) and the type of change (linear, u-shaped, or other) appeared to be specific to each drug. CONCLUSIONS: A variety of drug classes and individual medications were used to manage pain and sedation in hospitalized children. The variation in patterns of use reflects the heterogeneity of the dataset, comprising a wide range of ages and conditions in which analgesia, anesthesia, and sedation might be required. It was not possible to assess whether use of a specific medication was clinically appropriate, except to note use of medications in age subgroups without pediatric labeling.

OBJECTIVE: To describe the implementation of a system-wide, electronic medical record (EMR)-based quality improvement intervention targeting medication reconciliation (MedRec) in outpatient pediatrics and to test variables associated with the performance of MedRec. METHODS: This was a retrospective study using serial cross-sections of outpatient pediatric visits over a 5-year period set in a multispecialty children's integrated health care network in Florida, Delaware, Pennsylvania, and New Jersey. We reviewed 2 745 523 outpatient pediatric visits between 2005 and 2010. In 2007, the performance of MedRec was identified as critical to improving patient safety at our organization. A comprehensive intervention involved changes in the EMR, automated generation of medication lists, educational modules, and provider compliance reports. In 2009, quality-based financial incentives to physicians to perform MedRec were added. The outcome measure was documentation of MedRec performance. RESULTS: MedRec improved consistently over time, from a nadir of 0% in 2005 to a maximum of 71% in 2010. Performance of MedRec varied according to practice location as the intervention was rolled out. Throughout the study period, documentation of MedRec was consistently less likely for sick visits (adjusted odds ratio [aOR] for each year ranged from 0.44 to 0.68) but more likely if the provider placed a medication order during the visit (aOR: 1.70–2.15). Beginning in 2009, visits with providers eligible for the quality-based financial incentive were more likely to have had MedRec performed (aOR: 2.02 [2009] and 2.31 [2010]). CONCLUSIONS: A system-wide, EMR-based, outpatient pediatric quality improvement intervention was successful in improving documentation of the performance of MedRec, a national patient safety goal.

Optimizing patient/family caregiver satisfaction with emergency department (ED) encounters has advantages for improving patient health outcomes, adherence with medical plans, patient rights, and shared participation in care, provider satisfaction, improved health economics, institutional market share, and liability reduction. The variables that contribute to an optimal outcome in the pediatric ED setting have been less well investigated. The specific hypothesis tested was that patient/family caregiver-provider communication and 24-hour postdischarge phone contact would be associated with an increased frequency of highest possible satisfaction scores.A consecutive set of Press Ganey satisfaction survey responses between June and December 2009 in a large tertiary referral pediatric ED was evaluated. Press Ganey responses were subsequently linked to defined components of the electronic medical record associated with each survey respondent's ED visit to ascertain specific objective ED data. Multivariate modeling utilizing generalized linear equations was achieved to obtain a composite model of drivers of patient/caregiver satisfaction.Primary drivers of satisfaction and willingness to return or refer others to the ED were as follows: being informed about delays, ease of the insurance process, overall physician rating, registered nurse attention to needs, control of pain, and successful completion of postdischarge phone call to a family caregiver. Multiple wait time variables that were statistically significant in univariate modeling, including total length of time in the ED, time in waiting room, comfort of waiting room, time in treatment room, and play items, were not statistically significant once controlling for the other variables in the model. Type of insurance, race, patient age, or time of year did not influence the models.Achieving optimal patient/caregiver satisfaction scores in the pediatric ED is highly dependent on the quality of the interpersonal interaction and communication of ED activities. Wait time and other throughput variables are less important than perceived quality of the health interaction and interpersonal communication. Patient satisfaction has advantages greater than market share and should be considered a component of the care-delivery paradigm.

Purpose We demonstrated the feasibility of developing national estimates of pediatric inpatient medication use by analyzing data from a large administrative database. Methods Pediatric inpatient data were extracted from Premier Perspective® database to calculate the prevalence of use of specific medications among hospitalized children in 2008. The database was validated by comparing characteristics to the HCUP KID sample of pediatric hospitalizations for 2006. Prevalence was calculated by categorizing patients as ever or never having received a specific drug. Results The 10 drugs administered in the most pediatric hospitalizations were acetaminophen, lidocaine, ampicillin, gentamicin, fentanyl, ibuprofen, morphine, ondansetron, ceftriaxone, and albuterol. Conclusions Although the database is not a probability-based sample, it bears sufficient similarity to a probability-based sample of pediatric hospitalizations (HCUP KID) to serve as a starting point in developing national estimates of inpatient pediatric medication use. Over 500 drug entities were administered to hospitalized children, but most are used by small percentages of hospitalized patients. The small numbers of children using any one drug has implications for efforts to study efficacy and safety, describe off-label use, monitor adverse events, describe practice, and conduct comparative effectiveness research. Copyright © 2010 John Wiley & Sons, Ltd.

We compared survival and outcomes in process of care in female versus male infants born ≤32 weeks gestational age (GA). Data were obtained from the Alere database for infants born ≤32 weeks GA. Females were compared with males for demographics, complications, and care processes. Univariate and multivariate analysis was conducted using chi-square analysis, analysis of variance, or logistic regression. Of the infants included, 6086 female and 6721 males were included. Mean GA did not differ, males were born larger than females, and females were more likely to be born SGA. Males received more surfactant, developed more CLD, received more steroids, and more often required oxygen at discharge. Females were more likely to develop a patent ductus arteriosus. After controlling for body weight, GA, and small-for-GA status, females were more likely to survive (95.4% versus 93.6%, odds ratio 1.63, P < 0.01). Male sex did not play a role in other processes of care except for weaning to a crib. Male infants born ≤32 weeks GA have a decreased rate of survival and an increased rate of respiratory morbidity in spite of higher birth weight distributions. Sex did not play a role in other processes of care.

Aims More than half of infants exposed to opioids in utero develop neonatal abstinence syndrome (NAS) of severity to require pharmacological therapy. Current treatments are associated with prolonged hospitalization. We sought to optimize the dose of sublingual buprenorphine in the treatment of NAS. Design Randomized, Phase 1, open-label, active-control clinical trial comparing sublingual buprenorphine to oral morphine. Setting Large, urban, tertiary care hospital. Participants Twenty-four term infants requiring pharmacological treatment for NAS. Measurements Outcomes were neonatal safety, length of treatment and length of hospitalization. Findings Sublingual buprenorphine was safe and effective. Infants treated with buprenorphine had a 23-day length of treatment compared to 38 days for those treated with morphine (P = 0.01), representing a 40% reduction. Length of hospital stay in the buprenorphine group was reduced 24%, from 42 to 32 days (P = 0.05). Conclusions Sublingual buprenorphine was safe in NAS, with a substantial efficacy advantage over standard of care therapy with oral morphine.

Objectives To evaluate the performance of the early-onset sepsis (EOS) risk calculator in a cohort of neonates born to mothers with clinical chorioamnionitis, and to compare the diagnostic utility of the EOS calculator, clinical signs, and laboratory evaluations for correctly identifying EOS in this cohort. Study design This was a retrospective study of neonates born at ≥35 weeks of gestation to mothers with chorioamnionitis. The risk and management categories for all neonates were calculated using the EOS calculator, and these results were analyzed and compared with laboratory data and clinical signs. Results Of the 1159 neonates born to mothers with chorioamnionitis, 5 (0.43%) had culture-proven EOS. Data for calculation of EOS risk were available for 896 neonates, including the 5 neonates with culture-proven EOS. The management recommendation based on the calculator was no empiric antibiotic treatment for 67% of the neonates, including 2 of the 5 with EOS. All neonates with culture-proven EOS had abnormal complete blood counts and C-reactive protein levels at 6-12 hours. Three of the 5 neonates with EOS had clinical signs of sepsis. Conclusions The risk of EOS in neonates born to mothers with chorioamnionitis is low. The use of an EOS calculator may reduce the use of empiric antibiotics in chorioamnionitis-exposed neonates, but in our cohort, some neonates with culture-confirmed EOS would have been missed. A larger study is needed to evaluate whether limiting antibiotics to chorioamnionitis-exposed neonates with clinical and/or laboratory signs of infection can safely decrease antibiotic use.

OBJECTIVE: The purpose of this work was to compare the processes of care and to evaluate outcomes of premature neonates delivered to women with Medicaid managed care versus private insurance. DESIGN/METHODS: All of the infants born at RESULTS: Of the 24151 infants studied, 19046 (78.9%) had private insurance, and 5105 (21.1%) had Medicaid managed care. There were no differences in gestational age at birth; however, Medicaid managed care infants had lower birth weight, lower Apgar score at 5 minutes, increased incidence of necrotizing enterocolitis and bacterial sepsis, and longer length of stay. Of the surviving infants, more neonates with private insurance went home on oxygen and apnea monitors despite no differences found in the incidences of apnea or bronchopulmonary dysplasia between the groups. There were no differences in processes of care for feeding and respiratory milestones, but infants with Medicaid managed care weaned to an open crib later and had greater overall weight gain compared with infants with private insurance. CONCLUSIONS: We speculate that, in addition to the known impact of insurance status on well-being at birth, Medicaid managed care is independently associated with adverse neonatal outcomes in preterm infants, as well as differences in neonatal intensive care discharge processes.

To evaluate the relationship of weight of preterm infants when first placed into an open crib with days to full oral feedings, growth velocity and length of stay (LOS), and to identify unwarranted variation in incubator weaning after adjusting for severity indices. A retrospective study using the ParadigmHealth neonatal database from 2003 to 2006 reviewed incubator weaning to an open crib in appropriate-for–gestational-age (AGA) infants from 22 to weeks gestation. Primary outcome measurements included days to full oral (PO) feeding, weight gain from open crib to discharge and length of stay. Models were severity adjusted. To understand hospital practice variation, we also used a regression model to estimate the weight at open crib for the top 10 volume hospitals. In all 2908 infants met the inclusion criteria for the study. Their mean weight at open crib was 1850 g. On average every additional 100 g an infant weighed at the open crib was associated with increased time to full PO feeding by 0.8 days, decreased weight gained per day by 1 gram and increased LOS by 0.9 days. For the top 10 volume hospitals, severity variables alone accounted for 9% of the variation in weight at open crib, whereas the hospital in which the baby was treated accounted for an additional 19% of the variation. Even after controlling for severity, significant practice variation exists in weaning to an open crib, leading to potential delays in achieving full-volume oral feeds, decreased growth velocity and prolonged LOS.

Objective: Severe Retinopathy of Prematurity (ROP) is a primary cause of visual morbidity for very low birth weight infants. Known risk factors include short gestational age, low birth weight and supplemental oxygen exposure. Some studies have shown that Black infants are less at risk for severe ROP than White infants, however this finding has not been confirmed in studies designed to look at the risk of ROP and race/ethnicity specifically. The purpose of this study is to assess the relationship between the race/ethnicity of infants and the risk of severe ROP for a sample of 1,604 infants in 1,189 hospitals located in 39 states. Patients and methods: ParadigmHealth database records for surviving infants born between 1/1/2001 and 12/31/2004 with a birth weight less than or equal to 1250 g were included in this analysis (n = 1,604). Multivariate logistic regression was used to assess the association between race/ethnicity and risk for severe ROP. Models were adjusted for birth weight, gestational age, Apgar score, race and measures of illness severity including days on oxygen and mechanical ventilation, sepsis, intraventricular hemorrhage, patent ductus arteriosus, necrotizing enterocolitis and pneumothorax. Results: In the analytic data set, the distribution of maternal race was 47.2% White, 35.3% Black, 14.9% Hispanic and 3.2% Asian. Of these infants, 9.4% developed severe ROP; 6.6% for Blacks, 9.6% for Whites, 13.8% for Hispanics and 15.7% Asians. Compared to Black neonates, the unadjusted odds ratio for ROP among White infants was 1.5 (95% CI: 1.0, 2.3), for Hispanics 2.2 (95% CI: 1.4, 3.7) and for Asians 2.6 (95% CI: 1.2, 5.9). After adjustment for gestational age, birth weight and 1 minute Apgar score, the odds ratios increased to 2.0 (CI: 1.2, 3.2) for Whites, 2.7 (CI: 1.5, 4.8) for Hispanics and 5.3 (CI 1.9, 15.1) for Asians compared to Black neonates. Adjusting for additional markers of illness severity did not alter these results. Conclusions: Results revealed lower rates of ROP among Black confirming findings from earlier studies. Interestingly, relatively high rates of ROP were also found among Hispanic and Asian neonates compared to Black infants. Controlling for possibly confounding morbidities and measures of illness severity did not alter these results. Further research in this area is warranted.

To evaluate short-term outcomes associated with discordant twin pairs admitted to the NICU.A retrospective descriptive study comparing discordant twin pairs.Three hundred eighty-four discordant twin pairs were included. Mean gestational age of the twin pairs was 32.6 weeks (range, 24-39).The ParadigmHealth database was queried for all twin admissions from January 2001 to June 2004 admitted to 453 NICUs across the United States. Discordance was calculated for each twin set as defined as greater than 20% difference in birth weight. Exclusion criteria were death of a twin, congenital anomalies, or extracorporeal life support.Demographics, respiratory needs, feeding characteristics, complications, and discharge needs.A total of 384 discordant twin pairs met inclusion criteria. The larger twins required more ventilation/continuous positive airway pressure (55% vs 44%, P.01) and/or oxygen therapy (50% vs 41%, P = .02) compared with smaller twins. Smaller twins reached full oral (PO) feeds an average of 0.6 weeks later than larger twins (P.0001) but had more weight gain per day. Smaller twins transitioned to an open crib at lower weights but at slightly greater age. No differences were noted with necrotizing enterocolitis or apnea. Smaller twins had increased nosocomial infections. Mean length of stay was shorter (P = .0036) in the larger twin group. Only 33% of the twin pairs were discharged on the same day.Larger twins had more acute respiratory issues but achieved certain milestones more rapidly with fewer complications, thus leading to earlier discharge compared with their smaller twin counterparts.

OBJECTIVES. Our goals were to identify the trend of surfactant use over a 6-year period and to determine whether a relationship exists between the incidence of chronic lung disease in infants born weighing METHODOLOGY. Data regarding surfactant use, incidence of chronic lung disease, nasal continuous positive airway pressure use and duration, and demographic data were collected from the Alere (formerly ParadigmHealth) database from 2001 to 2006 (n = 3086). Groups were compared by using χ2 test, analysis of variance, or Student's t test. RESULTS. Use of surfactant has decreased over time from 67% in 2001 to 59.9% in 2006. Infants who received surfactant were more likely to develop chronic lung disease. Those who received >1 dose of surfactant were more likely to develop chronic lung disease when compared with infants treated with only 1 dose. Chronic lung disease rates have risen over time from 47.8% in 2001 to 57.8% in 2006. There was no difference in survival between groups. CONCLUSIONS. Despite the findings that surfactant use decreased during the study period and the rate of chronic lung disease increased, the data do not support a connection. Infants who receive surfactant are more likely to develop chronic lung disease, and chronic lung disease rates are stable in those infants not treated with surfactant. It is concerning, however, that 60% of infants not receiving surfactant developed chronic lung disease.

OBJECTIVE. In utero exposure to drugs of abuse can lead to neonatal abstinence syndrome, a condition that is associated with prolonged hospitalization. Buprenorphine is a partial μ-opioid agonist used for treatment of adult detoxification and maintenance but has never been administered to neonates with opioid abstinence syndrome. The primary objective of this study was to demonstrate the feasibility and, to the extent possible in this size of study, the safety of sublingual buprenorphine in the treatment of neonatal abstinence syndrome. Secondary goals were to evaluate efficacy relative to standard therapy and to characterize buprenorphine pharmacokinetics when sublingually administered.METHODS. We conducted a randomized, open-label, active-control study of sublingual buprenorphine for the treatment of opiate withdrawal. Thirteen term infants were allocated to receive sublingual buprenorphine 13.2 to 39.0 μg/kg per day administered in 3 divided doses and 13 to receive standard-of-care oral neonatal opium solution. Dose decisions were made by using a modified Finnegan scoring system.RESULTS. Sublingual buprenorphine was largely effective in controlling neonatal abstinence syndrome. Greater than 98% of plasma concentrations ranged from undetectable to ∼0.60 ng/mL, which is less than needed to control abstinence symptoms in adults. The ratio of buprenorphine to norbuprenorphine was larger than that seen in adults, suggesting a relative impairment of N-dealkylation. Three infants who received buprenorphine and 1 infant who received standard of care reached protocol-specified maximum doses and required adjuvant therapy with phenobarbital. The mean length of treatment for those in the neonatal-opium-solution group was 32 compared with 22 days for the buprenorphine group. The mean length of stay for the neonatal-opium-solution group was 38 days compared with 27 days for those in the buprenorphine group. Treatment with buprenorphine was well tolerated.CONCLUSIONS. Buprenorphine administered via the sublingual route is feasible and apparently safe and may represent a novel treatment for neonatal abstinence syndrome.

IMPORTANCE: Extubation failure is common in extremely preterm infants. The current paucity of data on the adverse long-term respiratory outcomes associated with reinitiation of mechanical ventilation prevents assessment of the risks and benefits of a trial of extubation in this population. OBJECTIVE: To evaluate whether exposure to multiple courses of mechanical ventilation increases the risk of adverse respiratory outcomes before and after adjustment for the cumulative duration of mechanical ventilation. DESIGN, SETTING, AND PARTICIPANTS: We performed a retrospective cohort study of extremely low-birth-weight (ELBW; birth weight

Heliox (Hx) gas has been shown to improve pulmonary function in infants, but methods for its delivery are invasive and problematic. To this end, we modified an Isolette (Hill-Rom Air-Shields) infant incubator (Hxl) to deliver Hx respiratory gas mixtures noninvasively while providing thermal stability for neonatal care in the Neonatal Intensive Care Unit (NICU). In vitro tests and in vivo animal studies were performed to compare the original design specifications and established baseline performance criteria for the Hxl design. The experimental environments at 50% and 80% relative humidity (RH) consisted of helium (He) with 21% and 50% O2 and control (C) of 21% and 50% O2 with the balance nitrogen (N2). Elapsed times to steady state (SS) and recovery time back to SS (OCDss) due to opening and closing the door were recorded for each variable. All rabbits survived and appeared comfortable during all experimental conditions. These data show that the newly designed Isolette provides similar thermal, O2, CO2, and RH responses as the control incubator. Based on these positive safety/efficacy studies, study of the therapeutic impact of Hxl care on neonatal growth and development is in progress.

To compare heliox to nitrogen-oxygen (nitrox) as a carrier gas for inducible nitric oxide (iNO) in the presence of pharmacologically inhaled bronchoconstriction. We hypothesized that respiratory resistance and gas exchange would improve when iNO is delivered with heliox.Interventional laboratory study.An academic medical research facility in the northeastern United States.Sedated, ventilated newborn piglets.Newborn piglets (n = 16; 2.3 +/- 0.1 kg) were placed on a flow-controlled ventilator and given intravenous Bethanecol (2 x 1 mg/kg followed by 1 mg/kg/hr) to induce bronchoconstriction. Piglets were randomized to heliox or nitrox (Fio2 = 0.3) and given 80 ppm iNO.Hemodynamics, blood chemistry, and pulmonary mechanics were recorded at 30-min intervals for 2 hrs. Bethanecol dosing increased inspiratory respiratory resistance (cm H2O/L/min; p.01) and decreased respiratory compliance (mL/cm H2O/kg; p.01). Following carrier gas assignment, hemodynamics and respiratory compliance were similar between groups and respiratory resistance decreased (p.01) in the heliox group. Over 2 hrs with iNO therapy, Paco2 increased (p.01) whereas blood pH decreased (p.01) in the heliox group. Respiratory resistance trended downward, oxygenation index improved (p.01), and blood methemoglobin levels trended higher for nitrox compared with heliox.The INOvent was effective for controlling heliox delivery of iNO. Despite marked reduction in respiratory resistance with heliox gas ventilation in a neonatal model of pharmacologic bronchoconstriction, nitrox might perform better as a delivery vehicle for iNO.