A prospective, randomized, controlled study of NIPPV versus nCPAP in preterm and term infants with respiratory distress syndrome

Abstract

Objective: To evaluate whether nasal intermittent positive pressure ventilation (NIPPV) compared with nasal continuous positive airway pressure (nCPAP) decreases the requirement for endotracheal ventilation in preterm and term infants with respiratory distress syndrome (RDS).

Methods: This was a single center, randomized, controlled trial. A total of 179 preterm and term infants with RDS were randomized to NIPPV (n = 88) or nCPAP (n = 91). The clinical data of enrolled infants including blood gas analysis, PaO2 /FiO2 ratio, incidence of intubation, and complications, if occurred, were recorded. The primary outcome was the need for endotracheal ventilation. The secondary outcome was the measurement of favorable outcome, which was defined as discharged without any respiratory support and feeding well and gaining weight. Analysis followed slightly modified intention to treat principle.

Results: Significantly less number of infants randomized to NIPPV group required intubation and mechanical ventilation compared with nCPAP group (11.4% vs. 20.9%, P < 0.05). A favorable outcome was more likely in infants randomized to NIPPV (93.2% vs. 84.6%, P < 0.05). In subgroup analysis, NIPPV was associated with reduced need for intubation in preterm (9.9% vs. 19.2%) and term (17.6% vs. 27.8%) infants, but the difference was statistically significant only in preterm infants(P < 0.05).

Conclusion: Treatment with NIPPV compared with nCPAP decreased the need for endotracheal ventilation and increased favorable outcome in preterm and term infants with RDS.

Trial registration: ClinicalTrials.gov NCT00780624.

Keywords: infant; mechanical ventilation; nasal continuous positive airway pressure; nasal intermittent positive pressure ventilation; neonatal respiratory distress syndrome; newborn.