Abstract | BACKGROUND: METHODS: 800 preterm infants with a gestational age at birth of between 24 weeks and 28 weeks plus 6 days (inclusive), weighing at least 500 g, requiring surfactant or continuous positive airway pressure for respiratory distress syndrome within 24 h of birth were randomly assigned in a one-to-one ratio to inhaled nitric oxide (5 parts per million) or placebo gas ( nitrogen gas) for a minimum of 7 days and a maximum of 21 days in a double-blind study done at 36 centres in nine countries in the European Union. Care providers and investigators were masked to the computer-generated treatment assignment. The primary outcome was survival without development of bronchopulmonary dysplasia at postmenstrual age 36 weeks. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00551642. FINDINGS: 399 infants were assigned to inhaled nitric oxide, and 401 to placebo. 395 and 400, respectively, were analysed. Treatment with inhaled nitric oxide and placebo did not result in significant differences in survival of infants without development of bronchopulmonary dysplasia (258 [65%] of 395 vs 262 [66%] of 400, respectively; relative risk 1.05, 95% CI 0.78-1.43); in survival at 36 weeks' postmenstrual age (343 [86%) of 399 vs 359 [90%] of 401, respectively; 0.74, 0.48-1.15); and in development of bronchopulmonary dysplasia (81 [24%] of 339 vs 96 [27%] of 358, respectively; 0.83, 0.58-1.17). INTERPRETATION: FUNDING:
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Authors | Jean-Christophe Mercier, Helmut Hummler, Xavier Durrmeyer, Manuel Sanchez-Luna, Virgilio Carnielli, David Field, Anne Greenough, Bart Van Overmeire, Baldvin Jonsson, Mikko Hallman, James Baldassarre, EUNO Study Group |
Journal | Lancet (London, England)
(Lancet)
Vol. 376
Issue 9738
Pg. 346-54
(Jul 31 2010)
ISSN: 1474-547X [Electronic] England |
PMID | 20655106
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright 2010 Elsevier Ltd. All rights reserved. |
Chemical References |
- Free Radical Scavengers
- Nitric Oxide
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Topics |
- Administration, Inhalation
- Bronchopulmonary Dysplasia
(complications, epidemiology, ethnology, prevention & control)
- Continuous Positive Airway Pressure
- Double-Blind Method
- Drug Administration Schedule
- European Union
(statistics & numerical data)
- Female
- Free Radical Scavengers
(administration & dosage)
- Gestational Age
- Humans
- Hypoxia, Brain
(etiology, prevention & control)
- Incidence
- Infant, Newborn
- Infant, Premature
- Male
- Nitric Oxide
(administration & dosage)
- Survival Analysis
- Treatment Outcome
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