4.5 Article

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

Journal

ACTA PAEDIATRICA
Volume 100, Issue 4, Pages 524-528

Publisher

WILEY
DOI: 10.1111/j.1651-2227.2010.02077.x

Keywords

Nitric oxide inhalation; Prematurity; Safety; School-age outcome

Categories

Funding

  1. American Academy of Pediatrics
  2. NINDS [R01 NS056313]
  3. INO Therapeutics/IKARIA

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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.

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