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PEDIATRICS Vol. 113 No. 3 March 2004, pp. 559-564

A Randomized Trial of Early Versus Standard Inhaled Nitric Oxide Therapy in Term and Near-Term Newborn Infants With Hypoxic Respiratory Failure

G. Ganesh Konduri, MD, Alfonso Solimano, MD, Gregory M. Sokol, MD, Joel Singer, PhD, Richard A. Ehrenkranz, MD, Nalini Singhal, MD, Linda L. Wright, MD, Krisa Van Meurs, MD, Eileen Stork, MD, Haresh Kirpalani, MD, Abraham Peliowski, MD for the Neonatal Inhaled Nitric Oxide Study Group

From the Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin

Objective. Inhaled nitric oxide (iNO) reduces the use of extracorporeal membrane oxygenation (ECMO)/incidence of death in term and near-term neonates with severe hypoxic respiratory failure. We conducted a randomized, double masked, multicenter trial to determine whether administration of iNO earlier in respiratory failure results in additional reduction in the incidence of these outcomes.

Methods. Neonates who were born at 34 weeks’ gestation were enrolled when they required assisted ventilation and had an oxygenation index (OI) 15 and <25 on any 2 measurements in a 12-hour interval. Infants were randomized to early iNO or to simulated initiation of iNO (control). Infants who had an increase in OI to 25 or more were given iNO as standard therapy.

Results. The trial enrollment was halted after 75% of target sample size was reached because of decreasing availability of eligible patients. The 150 infants who were given early iNO and 149 control infants had similar baseline characteristics. Arterial oxygen tension increased by >20 mm Hg in 73% of early iNO and 37% of control infants after study gas initiation. Control infants received standard iNO and deteriorated to OI >40 more often than infants who were given early iNO. The incidence of death (early iNO, 6.7% vs control, 9.4%), ECMO (10.7% vs 12.1%), and their combined incidence (16.7% vs 19.5%) were similar in both groups.

Conclusion. iNO improves oxygenation but does not reduce the incidence of ECMO/mortality when initiated at an OI of 15 to 25 compared with initiation at >25 in term and near-term neonates with respiratory failure.

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Key Words: persistent fetal circulation syndrome • respiratory insufficiency • randomized controlled trials • inhalation therapy • newborn infant

Abbreviations: iNO, inhaled nitric oxide • ECMO, extracorporeal membrane oxygenation • OI, oxygenation index • FIO₂, fraction of inspired oxygen • PaO₂, partial pressure of arterial oxygen

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Received for publication Apr 11, 2003; Accepted Sep 26, 2003.

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