Noninvasive inhaled nitric oxide does not prevent bronchopulmonary dysplasia in premature newborns.

Abstract

OBJECTIVE:

To assess the efficacy and safety of early, noninvasive inhaled nitric oxide (iNO) therapy in premature newborns who do not require mechanical ventilation.

STUDY DESIGN:

We performed a multicenter randomized trial including 124 premature newborns who required noninvasive supplemental oxygen within the first 72 hours after birth. Newborns were stratified into 3 different groups by birth weight (500-749, 750-999, 1000-1250 g) prior to randomization to iNO (10 ppm) or placebo gas (controls) until 30 weeks postmenstrual age. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age. Secondary outcomes included the need for and duration of mechanical ventilation, severity of BPD, and safety outcomes.

RESULTS:

There was no difference in the incidence of death or BPD in the iNO and placebo groups (42% vs 40%, P = .86, relative risk = 1.06, 0.7-1.6). BPD severity was not different between the treatment groups. There were no differences between the groups in the need for mechanical ventilation (22% vs 23%; P = .89), duration of mechanical ventilation (9.7 vs 8.4 days; P = .27), or safety outcomes including severe intracranial hemorrhage (3.4% vs 6.2%, P = .68).

CONCLUSIONS:

We found that iNO delivered noninvasively to premature infants who have not progressed to early respiratory failure is a safe treatment, but does not decrease the incidence or severity of BPD, reduce the need for mechanical ventilation, or alter the clinical course.

• Authors: John P Kinsella, Gary R Cutter, Robin H Steinhorn, Leif D Nelin, William F Walsh, Neil N Finer, Steven H Abman
• Journal: The Journal of pediatrics (J Pediatr) Vol. 165 Issue 6 Pg. 1104-1108.e1 (Dec 2014) ISSN: 1097-6833 [Electronic] United States
• PMID: 25063725 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
• Copyright: Copyright © 2014 Elsevier Inc. All rights reserved.

Chemical References

• Nitric Oxide

Topics

• Administration, Inhalation
• Bronchopulmonary Dysplasia (etiology, prevention & control)
• Early Medical Intervention (methods)
• Female
• Gestational Age
• Humans
• Infant, Newborn
• Infant, Premature
• Infant, Premature, Diseases (mortality, therapy)
• Male
• Nitric Oxide (administration & dosage)
• Oxygen Inhalation Therapy (adverse effects)
• Respiration, Artificial (statistics & numerical data)