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Title: Inhaled nitric oxide in preterm infants: An individual-patient data meta-analysis of randomized trials
Authors: Lisa M. Askie
Roberta A. Ballard
Gary R. Cutter
Carlo Dani
Diana Elbourne
David Field
Jean Michel Hascoet
Anna Maria Hibbs
John P. Kinsella
Jean Christophe Mercier
Wade Rich
Michael D. Schreiber
Pimol Wongsiridej
Nim V. Subhedar
Krisa P. Van Meurs
Merryn Voysey
Keith Barrington
Richard A. Ehrenkranz
Neil N. Finer
The University of Sydney
UCSF School of Medicine
University of Alabama at Birmingham
Azienda Ospedaliera Careggi
London School of Hygiene & Tropical Medicine
University of Leicester
Maternite Regionale de Nancy
Rainbow Babies and Children's Hosp.
University of Colorado School of Medicine
Universite Paris 7- Denis Diderot
University of California, San Diego
University of Chicago
Mahidol University
Liverpool Women's Hospital
Stanford University School of Medicine
Centre Hospitalier de L'Universite de Montreal
Yale University School of Medicine
Keywords: Medicine
Issue Date: 1-Oct-2011
Citation: Pediatrics. Vol.128, No.4 (2011), 729-739
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. Copyright © 2011 by the American Academy of Pediatrics.
ISSN: 10984275
Appears in Collections:Scopus 2011-2015

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