Neurodevelopmental Outcomes of Premature Infants with Severe Respiratory Failure Enrolled in a Randomized Controlled Trial of Inhaled Nitric Oxide

Susan R. Hintz, Krisa P. Van Meurs, R. Perritt, W. Kenneth Poole, Abhik Das, David K. Stevenson, Richard A. Ehrenkranz, James A. Lemons, Betty R. Vohr, Roy Heyne, David O. Childers, Myriam Peralta-Carcelen, Anna Dusick, Yvette R. Johnson, Brenda Morris, Robert Dillard, Yvonne Vaucher, Jean Steichen, Ira Adams-Chapman, Ganesh KonduriGary J. Myers, Marissa de Ungria, Jon E. Tyson, Rosemary D. Higgins

Research output: Contribution to journalArticlepeer-review

39 Scopus citations

Abstract

Objectives: We hypothesized that inhaled nitric oxide (iNO) would not decrease death or neurodevelopmental impairment (NDI) in infants enrolled in the National Institute of Child Health and Human Development Preemie iNO Trial (PiNO) trial, nor improve neurodevelopmental outcomes in the follow-up group. Study design: Infants <34 weeks of age, weighing <1500 g, with severe respiratory failure were enrolled in the multicenter, randomized, controlled trial. NDI at 18 to 22 months corrected age was defined as: moderate to severe cerebral palsy (CP; Mental Developmental Index or Psychomotor score Developmental Index <70), blindness, or deafness. Results: Of 420 patients enrolled, 109 who received iNO (52%) and 98 who received placebo (47%) died. The follow-up rate in survivors was 90%. iNO did not reduce death or NDI (78% versus 73%; relative risk [RR], 1.07; 95% CI, 0.95-1.19), or NDI or Mental Developmental Index <70 in the follow-up group. Moderate-severe CP was slightly higher with iNO (RR, 2.41; 95% CI, 1.01-5.75), as was death or CP in infants weighing <1000 g (RR, 1.22; 95% CI, 1.05-1.43). Conclusions: In this extremely ill cohort, iNO did not reduce death or NDI or improve neurodevelopmental outcomes. Routine iNO use in premature infants should be limited to research settings until further data are available.

Original languageEnglish (US)
Pages (from-to)16-22.e3
JournalJournal of Pediatrics
Volume151
Issue number1
DOIs
StatePublished - Jul 2007

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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