Respiratory morbidities in late preterm and term infants with myelomeningocele.

OBJECTIVE: To describe the incidence of respiratory morbidities in late preterm and term newborns with myelomeningocele (MMC) born by c-section. STUDY DESIGN: Single center retrospective cohort study of infants born between 34 0/7 and 40 6/7 weeks gestation with the diagnosis of MMC. The primary outcome was the incidence of respiratory morbidities and the secondary outcome was caffeine treatment for apnea at discharge. RESULTS: A total of  293 infants with MMC born by cesarean section were included in this cohort: 106 born late preterm, 120 early term, and 67 at term. Respiratory morbidity was present in 50.5% within the first 24 h after birth. Treatment with caffeine for persistent apnea or periodic breathing at discharge was present in 17.8% with an overall incidence of apnea throughout the hospital admission of 20.5%. CONCLUSION: There is a markedly increased risk of respiratory distress in late preterm and term infants with myelomeningocele at all gestational ages.

Milrinone Pharmacokinetics and Pharmacodynamics in Neonates with Persistent Pulmonary Hypertension of the Newborn.

Objective To describe the pharmacokinetics and pharmacodynamics of milrinone in infants with persistent pulmonary hypertension of the newborn (PPHN) and to explore the impact of age on milrinone disposition. Design Randomized, open label pilot study. Setting Multicenter; level 3 and level 4 neonatal intensive care units. Patients Six infants ≥34 weeks' gestational age and <10 days of life with persistent hypoxemia receiving inhaled nitric oxide. Intervention Intravenous milrinone lactate in one of two dosing regimens: (1) low dose, 20 mcg/kg bolus followed by 0.2 mcg/kg/minute, and (2) standard dose, 50 mcg/kg bolus followed by 0.5 mcg/kg/minute. Measurements and Main Results The final structural model was a two-compartment disposition model with interindividual variability estimated on clearance (CL). The estimated value of CL is 7.65 mL/minute/3.4 kg (3.05 mL/minute/kg). The addition of age improved the precision of the CL estimate, and CL increased with chronological age in days. The oxygenation index was highly variable within each participant and improved with time. There were no observed safety concerns in either dosing group. Conclusion The CL of milrinone in newborns with PPHN is reduced and increases with age. In this pilot study, we did not see significant pharmacodynamic or safety effects associated with drug exposure.

Definitions of extubation success in very premature infants: a systematic review.

OBJECTIVE: Studies of extubation in preterm infants often define extubation success as a lack of reintubation within a specified time window. However, the duration of observation that defines extubation success in preterm infants has not been validated. The purpose of this study was to systematically review published definitions of extubation success in very preterm infants and to analyse the effect of the definition of extubation success on the reported rates of reintubation. DESIGN: Studies including very preterm infants published between 1 January 2002 and 30 June 2012 that reported reintubation as an outcome were reviewed for definitions of extubation success. Stepwise multivariable linear regression was used to explore variables associated with rate of reintubation. RESULTS: Two independent reviewers performed the search with excellent agreement (κ=0.93). Of the 44 eligible studies, 31 defined a window of observation that ranged from 12 to 168 h (7 days). Extubation and reintubation criteria were highly variable. The mean±SD reintubation rate across all studies was 25±9%. In studies of infants with median birth weight (BW) ≤1000 g, reintubation rates steadily increased as the window of observation increased, without apparent plateau (p = 0.001). This trend was not observed in studies of larger infants (p = 0.85). CONCLUSIONS: Variability in the reported definitions of extubation success makes it difficult to compare extubation strategies across studies. The appropriate window of observation following extubation may depend on the population. In infants with BW ≤1000 g, even a week of observation may fail to identify some who will require reintubation.

Quality of reporting of neonatal and infant trials in high-impact journals.

OBJECTIVES: To perform a systematic review of the quality of reporting for randomized controlled trials (RCTs) with infants and neonates that were published in high-impact journals and to identify RCT characteristics associated with quality of reporting. METHODS: RCTs that enrolled infants younger than 12 months and were published in 2005-2009 in 6 pediatric or general medical journals were reviewed. Eligible RCTs were evaluated for the presence of 11 quality criteria selected from the Consolidated Standards of Reporting Trials guidelines. The relationships between quality of reporting and key study characteristics were tested with nonparametric statistics. RESULTS: Two reviewers had very good agreement regarding the eligibility of studies (κ = 0.85) and the presence of quality criteria (κ = 0.82). Among 179 eligible RCTs, reporting of the individual quality criteria varied widely. Only 50% included a flow diagram, but 99% reported the number of study participants. Higher quality of reporting was associated with greater numbers of study participants, publication in a general medical journal, and greater numbers of centers (P < .0001 for each comparison). Geographic region and positive study outcomes were not associated with reporting quality. CONCLUSIONS: The quality of reporting of infant and neonatal RCTs is inconsistent, particularly in pediatric journals. Therefore, readers cannot assess accurately the validity of many RCT results. Strict adherence to the Consolidated Standards of Reporting Trials guidelines should lead to improved reporting.