Inhaled Nitric Oxide in Preterm Infants Undergoing Mechanical Ventilation

doi:10.1056/NEJMoa061088

Volume 355:343-353		July 27, 2006		Number 4

Inhaled Nitric Oxide in Preterm Infants Undergoing Mechanical Ventilation

Roberta A. Ballard, M.D., William E. Truog, M.D., Avital Cnaan, Ph.D., Richard J. Martin, M.D., Philip L. Ballard, M.D., Ph.D., Jeffrey D. Merrill, M.D., Michele C. Walsh, M.D., David J. Durand, M.D., Dennis E. Mayock, M.D., Eric C. Eichenwald, M.D., Donald R. Null, M.D., Mark L. Hudak, M.D., Asha R. Puri, M.D., Sergio G. Golombek, M.D., Sherry E. Courtney, M.D., Dan L. Stewart, M.D., Stephen E. Welty, M.D., Roderic H. Phibbs, M.D., Anna Maria Hibbs, M.D., Xianqun Luan, M.S., Sandra R. Wadlinger, M.S., R.R.T., Jeanette M. Asselin, M.S., R.R.T., Christine E. Coburn, M.S.N., for the NO CLD Study Group

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Editorial
by Stark, A. R.

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ABSTRACT

Background Bronchopulmonary dysplasia in premature infants isassociated with prolonged hospitalization, as well as abnormalpulmonary and neurodevelopmental outcome. In animal models,inhaled nitric oxide improves both gas exchange and lung structuraldevelopment, but the use of this therapy in infants at riskfor bronchopulmonary dysplasia is controversial.

Methods We conducted a randomized, stratified, double-blind,placebo-controlled trial of inhaled nitric oxide at 21 centersinvolving infants with a birth weight of 1250 g or less whorequired ventilatory support between 7 and 21 days of age. Treatedinfants received decreasing concentrations of nitric oxide,beginning at 20 ppm, for a minimum of 24 days. The primary outcomewas survival without bronchopulmonary dysplasia at 36 weeksof postmenstrual age.

Results Among 294 infants receiving nitric oxide and 288 receivingplacebo birth weight (766 g and 759 g, respectively), gestationalage (26 weeks in both groups), and other characteristics weresimilar. The rate of survival without bronchopulmonary dysplasiaat 36 weeks of postmenstrual age was 43.9 percent in the groupreceiving nitric oxide and 36.8 percent in the placebo group(P=0.042). The infants who received inhaled nitric oxide weredischarged sooner (P=0.04) and received supplemental oxygentherapy for a shorter time (P=0.006). There were no short-termsafety concerns.

Conclusions Inhaled nitric oxide therapy improves the pulmonaryoutcome for premature infants who are at risk for bronchopulmonarydysplasia when it is started between 7 and 21 days of age andhas no apparent short-term adverse effects. (ClinicalTrials.govnumber, NCT00000548 [ClinicalTrials.gov] .)

Source Information

From Children's Hospital of Philadelphia (R.A.B., A.C., P.L.B., A.M.H., X.L., S.R.W., C.E.C.) and the University of Pennsylvania School of Medicine (J.D.M.) — both in Philadelphia; the University of Missouri, Kansas City (W.E.T.); Case Western Reserve University, Cleveland (R.J.M., M.C.W.); Children's Hospital and Research Center, Oakland, Calif. (D.J.D., J.M.A.); the University of Washington School of Medicine, Seattle (D.E.M.); Harvard Medical School, Boston (E.C.E.); the University of Utah Medical Center, Salt Lake City (D.R.N.); the University of Florida Health Science Center, Jacksonville (M.L.H.); the University of California Los Angeles School of Medicine, Los Angeles (A.R.P.); New York Medical College, Valhalla (S.G.G.); Long Island Jewish Health System, New Hyde Park, N.Y. (S.E.C.); the University of Louisville School of Medicine, Louisville, Ky. (D.L.S.); Ohio State University School of Medicine and Public Health, Columbus (S.E.W.); and the University of California at San Francisco, San Francisco (R.H.P.).

Address reprint requests to Dr. Ballard at Children's Hospital of Philadelphia, 3535 Market St., Suite 1584, Philadelphia, PA 19104, or at ballard{at}email.chop.edu.

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Inhaled Nitric Oxide in Preterm Infants — Correction
Ballard R. A.
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N Engl J Med 2007; 357:1444-1445, Oct 4, 2007. Correspondence

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