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Two-Year Outcomes of a Randomized Controlled Trial of Inhaled Nitric Oxide in Premature Infants
journal contributionposted on 08.07.2015, 14:58 by X. Durrmeyer, H. Hummler, M. Sanchez-Luna, V. P. Carnielli, David Field, A. Greenough, B. Van Overmeire, B. Jonsson, M. Hallman, J-C. Mercier, N. Marlow, Samantha Johnson, J. Baldassarre
BACKGROUND AND OBJECTIVES The European Union Nitric Oxide trial was designed to assess the potential benefits of inhaled nitric oxide (iNO) compared with placebo in infants with respiratory failure. This follow-up study evaluated respiratory, neurodevelopmental, and other outcomes for infants entered into the European Union Nitric Oxide trial to age 2 years. METHODS: In a multicenter, randomized, double-blind study, preterm infants born at <29 weeks’ gestation with moderate respiratory failure were allocated to receive iNO (5 ppm) or placebo for 7 to 21 days. Subjects underwent assessments at 1 and 2 years corrected for prematurity. RESULTS: At 36 weeks’ postmenstrual age, 696 of 792 infants were alive; 4 in the iNO arm subsequently died before age 2 years compared with 7 in the control arm. We evaluated 95% of the survivors at 12 months and 90% at 2 years. In the iNO arm, 244 of 363 (67.2%) infants had survived without disability at age 2 years compared with 270 of 374 (72.2%) who received placebo (P = .094). Mean (SD) cognitive composite scores (Bayley Scales of Infant and Toddler Development, third edition) were 94 (13) in the iNO group and 95 (14) in the placebo group; in the iNO group, 19% scored <85 and 9.5% developed cerebral palsy compared with 13.3% and 9%, respectively. There were no significant differences in hospitalizations overall or due to respiratory illness in use of home oxygen therapy or respiratory medications, in growth, or in other health outcomes. CONCLUSIONS: At 2 years of age, low-dose (5 ppm) iNO started early (<24 hours after birth) for a median of 20 days did not affect neurodevelopmental or other health outcomes.
: INO Therapeutics LLC, a subsidiary of Ikaria, Inc (Hampton, NJ), sponsored the study. Employees of Ikaria performed data management and statistical analysis, and a representative of Ikaria participated as part of the steering committee. The analysis of the data and preparation of this manuscript was performed by the study steering committee who had access to all study data. Editorial support for preparation of the manuscript was provided by Peloton Advantage, LLC, Parsippany, New Jersey
CitationPediatrics, 2013, 132 (3), pp. E695-E703 (9)
Author affiliation/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/School of Medicine/Department of Health Sciences
VersionVoR (Version of Record)
PublisherAmerican Academy of Pediatrics
Science & TechnologyLife Sciences & BiomedicinePediatricsPEDIATRICSinhaled nitric oxidepremature infantsgrowthdevelopmental outcomesrandomized controlled trialLOW-BIRTH-WEIGHTNEURODEVELOPMENTAL OUTCOMESPRETERM INFANTSBRONCHOPULMONARY DYSPLASIACLASSIFICATION-SYSTEMRESPIRATORY-FAILURECHILDREN BORNMORTALITYBRAIN