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Updated: Jun 5, 2026

A Novel Inhalation Mask System to Deliver High Concentrations of Nitric Oxide Gas in Spontaneously Breathing Subjects

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Inhaled nitric oxide in preterm infants: a systematic review.

Pamela K Donohue¹, Maureen M Gilmore, Elizabeth Cristofalo

¹Department of Pediatrics, Johns Hopkins School of Medicine, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA. pdonohue@jhmi.edu

|January 12, 2011

Summary

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Inhaled nitric oxide (iNO) did not reduce mortality or bronchopulmonary dysplasia (BPD) in preterm infants. However, iNO showed a small benefit in reducing the combined outcome of death or BPD.

Area of Science:

Neonatal Medicine
Respiratory Physiology
Clinical Trials

Background:

Inhaled nitric oxide (iNO) efficacy for preterm infant respiratory failure is debated.
Previous studies yielded variable and contradictory findings.

Purpose of the Study:

To systematically review evidence on iNO use in preterm infants (≤34 weeks gestation) receiving respiratory support.
To assess iNO's impact on mortality, bronchopulmonary dysplasia (BPD), and neurodevelopmental outcomes.

Main Methods:

Comprehensive literature search of multiple databases (Medline, Embase, Cochrane, PsycInfo, ClinicalTrials.gov) and conference proceedings.
Inclusion of 14 randomized controlled trials and 8 follow-up/observational studies.
Independent data abstraction focusing on mortality, BPD, composite death/BPD, and neurodevelopmental impairment.

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Main Results:

No significant difference in NICU mortality (RR: 0.97) or BPD at 36 weeks (RR: 0.93) between iNO and control groups.
A small but significant reduction in the composite outcome of death or BPD (RR: 0.93) was observed with iNO.
No evidence of difference in cerebral palsy, overall neurodevelopmental impairment, or cognitive impairment.

Conclusions:

iNO demonstrated a 7% reduction in the composite outcome of death or BPD in preterm infants, but not in death or BPD alone.
Current evidence does not support routine iNO use in preterm infants with respiratory failure outside of clinical trials.