Nasal High-Frequency Oscillatory Ventilation in Preterm Infants with Moderate Respiratory Distress Syndrome: A Multicenter Randomized Clinical Trial

Abstract

Objective: To determine whether nasal high-frequency oscillatory ventilation (NHFOV) as a primary mode of respiratory support as compared with nasal continuous airway pressure (NCPAP) will reduce the need for invasive mechanical ventilation in preterm infants (260/7-336/7 weeks of gestational age [GA]) with respiratory distress syndrome (RDS).

Methods: This multicenter randomized controlled trial was conducted in 18 tertiary neonatal intensive care units in China. A total of 302 preterm infants born at a GA of 260/7-336/7 weeks with a diagnosis of RDS were randomly assigned to either the NCPAP (n = 150) or the NHFOV (n = 152) group. The primary outcome was the need for invasive mechanical ventilation during the first 7 days after birth.

Results: Treatment failure occurred in 15 of 152 infants (9.9%) in the -NHFOV group and in 26 of 150 infants (17.3%) in the NCPAP group (95% CI of risk difference: -15.2 to 0.4, p = 0.06). In the subgroup analysis, NHFOV resulted in a significantly lower rate of treatment failure than did NCPAP in the strata of 26+0/7-29+6/7weeks of GA (11.9 vs. 32.4%, 95% CI of risk difference: -39.3 to -1.7, p = 0.03) and birth weight <1,500 g (10.4 vs. 29.6%, 95% CI of risk difference: -33.8 to -4.6, p = 0.01). The rate of thick secretions causing an airway obstruction was higher in the NHFOV group than in the NCPAP group (13.8 vs. 5.3%, 95% CI of risk difference: 1.9-15.1, p = 0.01). No significant differences in other secondary outcomes were found between the NHFOV and NCPAP groups.

Conclusions: NHFOV was not superior to NCPAP with regard to the primary outcome when applied as the primary respiratory support for RDS in infants between 26+0/7 and 33+6/7 weeks of GA. In the subgroup analysis, NHFOV seemed to improve effectiveness than NCPAP in preterm infants <30 weeks of GA.

Trial registration: ClinicalTrials.gov NCT03099694.

Keywords: Nasal high-frequency oscillatory ventilation; Preterm infants; Respiratory distress syndrome.