Safety and efficacy of inhaled nitric oxide treatment for premature infants with respiratory distress syndrome: follow-up evaluation at early school age

Acta Paediatr. 2011 Apr;100(4):524-8. doi: 10.1111/j.1651-2227.2010.02077.x. Epub 2010 Dec 1.


Aims: The aims of the study were to assess the long-term safety and compare neurodevelopmental outcomes in school-age children born prematurely who received inhaled nitric oxide or placebo during the first week of life in a randomized, double-blinded study. Children treated with inhaled nitric oxide had previously been shown to have decreased intraventricular haemorrhage and periventricular leukomalacia as newborns and decreased cognitive impairment at 2 years (L.W. Doyle and P.J. Anderson. (2005) Arch Dis Child Fetal Neonatal Ed, 90, F484-F8).

Methods: It is follow-up study of medical outcomes, neurodevelopmental assessment and school readiness in 135 of 167 (81%) surviving premature infants seen at 5.7±1.0 years.

Results: Compared to placebo-treated children (n=65), iNO-treated children (n=70) demonstrated no difference in growth parameters, school readiness or need for subsequent hospitalization. However, iNO-treated children were less likely to have multiple chronic morbidities or technology dependence (p=0.05). They also had less functional disability (p=0.05).

Conclusion: These results demonstrate the long-term safety of iNO in premature infants. Furthermore, iNO treatment may improve health status by decreasing the incidence of severe ongoing morbidities and technology dependence and may also decrease the incidence of educational and community functional disability of premature infants at early school age.

Trial registration: NCT00152542.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Child
  • Developmental Disabilities / chemically induced
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Infant, Newborn
  • Infant, Premature
  • Infant, Premature, Diseases / drug therapy*
  • Male
  • Nervous System Diseases / chemically induced
  • Nitric Oxide / administration & dosage
  • Nitric Oxide / adverse effects
  • Nitric Oxide / therapeutic use*
  • Respiratory Distress Syndrome, Newborn / drug therapy*
  • Treatment Outcome
  • Vasodilator Agents / administration & dosage
  • Vasodilator Agents / adverse effects
  • Vasodilator Agents / therapeutic use*


  • Vasodilator Agents
  • Nitric Oxide

Associated data