CommentaryRecommendations for the Use of Inhaled Nitric Oxide Therapy in Premature Newborns with Severe Pulmonary Hypertension
Section snippets
iNO for the Prevention of Bronchopulmonary Dysplasia
iNO is uniquely suited to the treatment of PPHN due to its selectivity for the pulmonary circulation, the absence of toxicities when used at low doses, and its demonstrated efficacy in decreasing the need for treatment with extracorporeal life support.3, 4 The effectiveness of iNO in the near-term and term newborn is largely due to its properties as a selective pulmonary vasodilator; however, numerous laboratory studies also demonstrated other important effects, such as decreasing lung
iNO for the Treatment of Severe PH in the Preterm Infant
Although the focus of the prior randomized, controlled trials was to test the role of iNO in BPD prevention, the potential role for iNO in preterm infants for the acute management of severe hypoxemic respiratory failure has not been fully addressed. In particular, there is a subset of premature newborns with severe PPHN for which iNO may likely be a safe and effective therapy. PPHN in premature newborns (associated with prolonged oligohydramnios, pulmonary hypoplasia, and other causes) is
Controversies
Although the use of iNO in premature infants with PPHN was not addressed in the AAP Statement, the National Institutes of Health Consensus Statement concluded that “there are rare clinical situations, including PH or hypoplasia, that have been inadequately studied in which iNO may have benefit in infants <34 weeks gestation” and that “use in this population should be left to clinical discretion.” Unfortunately, a proper randomized control trial (RCT) of iNO in premature newborns with severe
Recommendations
Based on the above observations, the Pediatric Pulmonary Hypertension Network proposes the following recommendations for the role of iNO in premature newborns:
- (1)
iNO therapy should not be used in premature infants for the prevention of BPD, as multicenter studies data have failed to consistently demonstrate efficacy for this purpose;
- (2)
iNO therapy can be beneficial for preterm infants with severe hypoxemia that is primarily due to PPHN physiology rather than parenchymal lung disease, particularly if
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Cited by (0)
Authors are the site PIs and advisory board members for the Pediatric Pulmonary Hypertension Network. J.K., S.A., and R.S. have received honoraria from Scientific Therapeutics Information, Inc, through Ikaria. D.I. and B.H. serve as a consultant for Actelion, Bayer, Eli Lilly, and United Therapeutics, contracted through The University of Colorado and Children's Hospital of Philadelphia, respectively. E.R. has received consulting fees from Actelion, Geliad, and Ikaria, and New York-Presbyterian/Columbia University Medical Center has received grant support from Actelion, Gilead, GlaxoSmithKline, and United Therapeutics. M.M. is the site PI for industry sponsored clinical trials with Ikaria, United Therapeutics, and GlaxoSmithKline. R.S. serves as Associate Editor for The Journal. S.A. serves on the Editorial Board of The Journal. The other authors declare no conflicts of interest.