Neurodevelopmental outcomes of premature infants with severe respiratory failure enrolled in a randomized controlled trial of inhaled nitric oxide.

OBJECTIVES: We hypothesized that inhaled nitric oxide (iNO) would not decrease death or neurodevelopmental impairment (NDI) in infants enrolled in the National Institute of Child Health and Human Development Preemie iNO Trial (PiNO) trial, nor improve neurodevelopmental outcomes in the follow-up group. STUDY DESIGN: Infants <34 weeks of age, weighing <1500 g, with severe respiratory failure were enrolled in the multicenter, randomized, controlled trial. NDI at 18 to 22 months corrected age was defined as: moderate to severe cerebral palsy (CP; Mental Developmental Index or Psychomotor score Developmental Index <70), blindness, or deafness. RESULTS: Of 420 patients enrolled, 109 who received iNO (52%) and 98 who received placebo (47%) died. The follow-up rate in survivors was 90%. iNO did not reduce death or NDI (78% versus 73%; relative risk [RR], 1.07; 95% CI, 0.95-1.19), or NDI or Mental Developmental Index <70 in the follow-up group. Moderate-severe CP was slightly higher with iNO (RR, 2.41; 95% CI, 1.01-5.75), as was death or CP in infants weighing <1000 g (RR, 1.22; 95% CI, 1.05-1.43). CONCLUSIONS: In this extremely ill cohort, iNO did not reduce death or NDI or improve neurodevelopmental outcomes. Routine iNO use in premature infants should be limited to research settings until further data are available.

Association between fluid intake and weight loss during the first ten days of life and risk of bronchopulmonary dysplasia in extremely low birth weight infants.

OBJECTIVE: To demonstrate the association between fluid intake and weight loss during the first 10 days of life and the risk of bronchopulmonary dysplasia (BPD) in extremely low birth weight (ELBW) infants. STUDY DESIGN: A retrospective analysis of data from a cohort of ELBW infants enrolled in the Neonatal Research; 1,382 infants with birth weight between 401 and 1,000 g were randomized. The daily fluid intake and weight loss during the first 10 days of life were compared between the infants who survived without BPD and those who either died or developed BPD. Demographic and clinical neonatal variables were also compared. Multivariate logistic regression was used to analyze the effect of fluid intake and weight loss on death or BPD, controlling for demographic and clinical factors that are significantly associated with BPD by univariate analysis. RESULTS: 585 infants survived without BPD and 797 infants either died or developed BPD. Univariate analysis showed that the daily fluid intakes were higher (day 2-10) and weight loss less (day 6-9) in the group of infants who either died or developed BPD. In addition, lower birth weight, lower gestational age, male gender, lower 1 and 5-minute Apgar Scores, higher oxygen requirement at 24 hours of age, longer duration of assisted ventilation, use of postnatal steroids for BPD and presence of severe intraventricular hemorrhage, proven necrotizing enterocolitis, patent ductus arteriosus, and late onset sepsis, were associated with higher incidence of death or BPD. The adjusted risk of higher fluid intake and less weight loss during the first 10 days of life remained significantly related to death or BPD. CONCLUSION: In this cohort of ELBW infants treated during the post surfactant era, higher fluid intake and less weight loss during the first 10 days of life were associated with an increased risk of BPD. The finding suggests that careful attention to fluid balance might be an important means to reduce the incidence of BPD.

Enterobacter sakazakii is a rare cause of neonatal septicemia or meningitis in VLBW infants.

To determine the rates of Enterobacter sakazakii (ES) infections among very low birth weight infants, culture data from the National Institute of Child Health and Human Development Neonatal Research Network were reviewed. Only one case of ES sepsis was identified among 10660 neonates. These data suggest that outside of the epidemic situation, ES is very rare in very low birth weight infants.