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

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.