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Randomized Controlled Trial
. 2014 Dec;165(6):1104-1108.e1.
doi: 10.1016/j.jpeds.2014.06.018. Epub 2014 Jul 22.

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

John P Kinsella  1 , Gary R Cutter  2 , Robin H Steinhorn  3 , Leif D Nelin  4 , William F Walsh  5 , Neil N Finer  6 , Steven H Abman  7
Affiliations
Randomized Controlled Trial

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

John P Kinsella et al. J Pediatr. 2014 Dec.

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.

Trial registration: ClinicalTrials.gov NCT00955487.

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Conflict of interest statement

The authors declare no conflicts of interest.

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References

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