Non-invasive high-frequency ventilation versus bi-phasic continuous positive airway pressure (BP-CPAP) following CPAP failure in infants <1250 g: a pilot randomized controlled trial

Abstract

Objective: Non-invasive high-frequency ventilation (NIHFV), a relatively new modality, is gaining popularity despite limited data. We sought to evaluate the effectiveness of NIHFV versus bi-phasic continuous positive airway pressure (BP-CPAP) in preterm infants failing CPAP.

Study design: Infants with BW<1250 g on CPAP were randomly assigned to NIHFV or BP-CPAP if they met pre-determined criteria for CPAP failure. Infants were eligible for randomization after 72 h age and until 2000 g. Guidelines for adjustment of settings and criteria for failure of assigned mode were implemented. The primary aim was to assess feasibility of a larger trial. In addition, failure of assigned non-invasive respiratory support (NRS) mode, invasive mechanical ventilation (MV) 72 h and 7 days post-randomization, and bronchopulmonary dysplasia (BPD) were assessed.

Results: Thirty-nine infants were randomized to NIHFV (N=16) or BP-CPAP (N=23). There were no significant differences in mean (s.d.) postmenstrual age (28.6 (1.5) versus 29.0 (2.3) weeks, P=0.47), mean (s.d.) weight at randomization (965.0 (227.0) versus 958.1 (310.4) g, P=0.94) or other baseline demographics between the groups. Failure of assigned NRS mode was lower with NIHFV (37.5 versus 65.2%, P=0.09), although not statistically significant. There were no differences in rates of invasive MV 72 h and 7 days post-randomization or BPD.

Conclusion: NIHFV was not superior to BP-CPAP in this pilot study. Effectiveness of NIHFV needs to be proven in larger multi-center, appropriately powered trials before widespread implementation.

Trial registration: ClinicalTrials.gov NCT02051491.