Inhaled nitric oxide in preterm infants: an individual-patient data meta-analysis of randomized trials.

Abstract:

BACKGROUND:Inhaled nitric oxide (iNO) is an effective therapy for pulmonary hypertension and hypoxic respiratory failure in term infants. Fourteen randomized controlled trials (n = 3430 infants) have been conducted on preterm infants at risk for chronic lung disease (CLD). The study results seem contradictory. DESIGN/METHODS:Individual-patient data meta-analysis included randomized controlled trials of preterm infants (<37 weeks' gestation). Outcomes were adjusted for trial differences and correlation between siblings. RESULTS:Data from 3298 infants in 12 trials (96%) were analyzed. There was no statistically significant effect of iNO on death or CLD (59% vs 61%: relative risk [RR]: 0.96 [95% confidence interval (CI): 0.92-1.01]; P = .11) or severe neurologic events on imaging (25% vs 23%: RR: 1.12 [95% CI: 0.98-1.28]; P = .09). There were no statistically significant differences in iNO effect according to any of the patient-level characteristics tested. In trials that used a starting iNO dose of >5 vs ≤ 5 ppm there was evidence of improved outcome (interaction P = .02); however, these differences were not observed at other levels of exposure to iNO. This result was driven primarily by 1 trial, which also differed according to overall dose, duration, timing, and indication for treatment; a significant reduction in death or CLD (RR: 0.85 [95% CI: 0.74-0.98]) was found. CONCLUSIONS:Routine use of iNO for treatment of respiratory failure in preterm infants cannot be recommended. The use of a higher starting dose might be associated with improved outcome, but because there were differences in the designs of these trials, it requires further examination.

journal_name

Pediatrics

journal_title

Pediatrics

authors

Askie LM,Ballard RA,Cutter GR,Dani C,Elbourne D,Field D,Hascoet JM,Hibbs AM,Kinsella JP,Mercier JC,Rich W,Schreiber MD,Wongsiridej PS,Subhedar NV,Van Meurs KP,Voysey M,Barrington K,Ehrenkranz RA,Finer NN,Meta-analys

doi

10.1542/peds.2010-2725

subject

Has Abstract

pub_date

2011-10-01 00:00:00

pages

729-39

issue

4

eissn

0031-4005

issn

1098-4275

pii

peds.2010-2725

journal_volume

128

pub_type

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