A Three-Arm Randomized, Controlled Trial of Different Nasal Interfaces on the Safety and Efficacy of Nasal Intermittent Positive-Pressure Ventilation in Preterm Newborns.

OBJECTIVES

To compare the safety and efficacy of different nasal interfaces for delivering non invasive positive pressure ventilation (NIPPV) in preterm neonates.

METHODS

In this three-arm parallel group stratified nonblinded randomized trial involving 210 preterm neonates the participants were randomly allocated to 'nasal mask', 'nasal prongs' and '4 hourly rotation of masks and prongs' groups in a 1:1:1 ratio. The groups were further stratified by gestational age (26-31 wk versus 32-36 wk) and indication of NIPPV (primary versus post extubation). Primary outcome was incidence of NIPPV failure within 72 h of initiation. Secondary outcomes were moderate/severe nasal injury, requirement of surfactant post randomization, total duration of respiratory support, duration of NICU stay, common neonatal morbidities and mortality.

RESULTS

Primary analysis revealed that mask group was superior to prongs and rotation groups in terms of reduction in NIPPV failure within 72 h (8.6%, 24.3%, 22.8%, p = 0.033), decreased incidence of moderate/severe nasal injury (8.6%, 22.8%, 11.4% p = 0.038), decreased requirement of surfactant (20%, 38.6%, 42.8%, p = 0.01) and reduction in total duration of respiratory support [median (interquartile range)-6 (3, 10) d, 7.7 (4.9, 19.2) d, 7 (5.5, 18.5) d, p = 0.005]. Post hoc analysis confirmed that nasal mask was superior to prongs with respect to primary outcome (p = 0.012) and also reduced surfactant requirement compared to both prongs (p = 0.015) and rotation (p = 0.003) groups. Other pairwise comparisons were not statistically significant.

CONCLUSIONS

Administering NIPPV by nasal mask significantly decreases the incidence of NIPPV failure within first 72 h compared to nasal prongs and also reduces the requirement of surfactant compared to both prongs and rotation groups.