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Published on: May 4, 2021
NIH consensus development conference: Inhaled nitric oxide therapy for premature infants.
F Sessions Cole1, Claudia Alleyne, John D E Barks
1Department of Pediatrics, Division of Newborn Medicine, Washington University School of Medicine, and St. Louis Children’s Hospital, St. Louis, Missouri, USA.
NIH Consensus and State-Of-The-Science Statements
|November 3, 2010
Summary
Current evidence does not support inhaled nitric oxide for premature infants requiring respiratory support. Further research is needed to clarify its role in specific conditions like pulmonary hypertension, despite promising basic science findings.
Area of Science:
- Neonatology and Pediatric Pulmonology
- Evidence-Based Medicine
- Clinical Trial Design
Background:
- Assessment of inhaled nitric oxide (iNO) efficacy in premature infants (<34 weeks gestation) requiring respiratory support.
- Review of data for early routine, early rescue, and later rescue iNO regimens.
- Focus on premature infants at risk for bronchopulmonary dysplasia.
Purpose of the Study:
- To assess the efficacy and safety of inhaled nitric oxide in premature infants (<34 weeks gestation).
- To provide a responsible evaluation of data for healthcare providers, patients, and the public.
- To guide clinical practice regarding iNO use in this vulnerable population.
Main Methods:
- A 16-member expert panel convened to review available scientific data.
- Presentations by 18 experts and a systematic literature review informed the panel's assessment.
- Scientific evidence was prioritized over anecdotal reports.
Main Results:
- Available evidence does not support the use of inhaled nitric oxide in routine, early, or later rescue regimens for premature infants.
- Potential benefits may exist in rare cases like pulmonary hypertension or hypoplasia, but these are inadequately studied.
- Basic research shows promise for iNO in lung development, but clinical trial results have been limited.
Conclusions:
- Inhaled nitric oxide is not recommended for routine use in premature infants (<34 weeks gestation) based on current data.
- Further research is crucial to understand the gap between basic science findings and clinical outcomes.
- Future trials should investigate optimal timing, dose, and duration of iNO therapy.
- Marketing of iNO for premature infants should be avoided pending further evidence.
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