Inhaled Nitric Oxide in Preterm Infants Undergoing Mechanical Ventilation

Inhaled Nitric Oxide in Preterm Infants Undergoing Mechanical Ventilation,Roberta A. Ballard,William E. Truog,Avital Cnaan,Richard J. Martin,Philip L.

Inhaled Nitric Oxide in Preterm Infants Undergoing Mechanical Ventilation   (Citations: 54)
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Roberta A. Ballard, William E. Truog, Avital Cnaan, Richard J. Martin, Philip L. Ballard, Jeffrey D. Merrill, Michele C. Walsh, David J. Durand, Dennis E. Mayock, Eric C. Eichenwald, Donald R. Null, Mark L. Hudak
Background Bronchopulmonary dysplasia in premature infants is associated with prolonged hospitalization, as well as abnormal pulmonary and neurodevelopmental outcome. In animal models, inhaled nitric oxide improves both gas exchange and lung struc- tural development, but the use of this therapy in infants at risk for bronchopulmo- nary dysplasia is controversial. Methods We conducted a randomized, stratified, double-blind, placebo-controlled trial of in- haled nitric oxide at 21 centers involving infants with a birth weight of 1250 g or less who required ventilatory support between 7 and 21 days of age. Treated infants re- ceived decreasing concentrations of nitric oxide, beginning at 20 ppm, for a mini- mum of 24 days. The primary outcome was survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age. Results Among 294 infants receiving nitric oxide and 288 receiving placebo birth weight (766 g and 759 g, respectively), gestational age (26 weeks in both groups), and other characteristics were similar. The rate of survival without bronchopulmonary dys- plasia at 36 weeks of postmenstrual age was 43.9 percent in the group receiving nitric oxide and 36.8 percent in the placebo group (P = 0.042). The infants who re- ceived inhaled nitric oxide were discharged sooner (P = 0.04) and received supple- mental oxygen therapy for a shorter time (P = 0.006). There were no short-term safety concerns. Conclusions Inhaled nitric oxide therapy improves the pulmonary outcome for premature infants who are at risk for bronchopulmonary dysplasia when it is started between 7 and 21 days of age and has no apparent short-term adverse effects. ( number, NCT00000548.)
Published in 2010.
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