Noninvasive ventilation for respiratory distress syndrome: a randomized controlled trial

Abstract

Context: Strategies for reducing exposure to endotracheal ventilation through the use of early noninvasive ventilation has proven to be safe and effective, but the option with the greatest benefits needs to be determined.

Objective: To determine, in infants with respiratory distress syndrome, if early nasal intermittent positive-pressure ventilation (NIPPV) compared with nasal continuous positive airway pressure (NCPAP) decreases the need for mechanical ventilation.

Patients and methods: In this single-center, randomized controlled trial, infants (gestational ages 26 to 33/7 weeks) with respiratory distress syndrome were randomly assigned to receive early NIPPV or NCPAP. Surfactant was administered as rescue therapy. The primary outcome was the need for mechanical ventilation within the first 72 hours of life.

Results: A total of 200 infants, 100 in each arm, were randomly assigned. Rates of the primary outcome did not differ significantly between the NIPPV (25%) and NCPAP (34%) groups (relative risk [RR]: 0.71 [95% confidence interval (CI): 0.48–1.14]). In posthoc analysis, from 24 to 72 hours of life, significantly more infants in the NIPPV group remained extubated compared with those in the NCPAP groups (10 vs 22%; RR: 0.45 [95% CI: 0.22–0.91]). This difference was also noted in the group of infants who received surfactant therapy, NIPPV (10.9%), and NCPAP (27.1%) (RR: 0.40 [95% CI: 0.18–0.86]).

Conclusions: Early NIPPV did not decrease the need for mechanical ventilation compared with NCPAP, overall, in the first 72 hours of life. However, further studies to assess the potential benefits of noninvasive ventilation are warranted, especially for the most vulnerable or preterm infants.

Trial registration: ClinicalTrials.gov NCT00821119.