Recruitment for the Novel Pilot Trial completed

High continuous positive airway pressures versus non-invasive positive pressure ventilation in preterm neonates: protocol for a multicentre pilot randomised controlled trial

Introduction: Low pressure nasal continuous positive airway pressure (nCPAP) has long been the mainstay of non-invasive respiratory support for preterm neonates, at a constant distending pressure of 5-8 cmH2O. When traditional nCPAP pressures are insufficient, other modes including nasal intermittent positive pressure ventilation (NIPPV) are used. In recent years, high nCPAP pressures (≥9 cmH2O) have also emerged as an alternative. However, the comparative benefits and risks of these modalities remain unknown.

Methods and analysis: In this multicentre pilot randomised controlled trial, infants <29 weeks' gestational age (GA) who either: (A) fail treatment with traditional nCPAP or (B) being extubated from invasive mechanical ventilation with mean airway pressure ≥10 cmH2O, will be randomised to receive either high nCPAP (positive end-expiratory pressure 9-15 cmH2O) or NIPPV (target mean Paw 9-15 cmH2O). Primary outcome is feasibility of the conduct of a larger, definitive trial as assessed by rates of recruitment and protocol violations. The main secondary outcome is failure of assigned treatment within 7 days postrandomisation. Multiple other clinical outcomes including bronchopulmonary dysplasia will be ascertained. All randomised participants will be analysed using intention to treat. Baseline and demographic variables as well as outcomes will be summarised and compared using univariate analyses, and a p<0.05 will be considered significant.

STRENGTHS AND LIMITATIONS OF THIS STUDY

Use of nasal continuous positive airway pressure (nCPAP) in preterm neonates has traditionally been limited to 8 cmH2O; alternative non-invasive modes like nasal intermittent positive pressure ventilation are commonly used when more support is needed. This protocol of a multicentre pilot trial outlines the study design and outcome measures to determine feasibility of a larger trial comparing high nCPAP (9–15 cmH2O) versus nasal intermittent positive pressure ventilation. As a pragmatic study, various aspects of clinical care, including choice of settings, devices and interfaces used will be at discretion of the clinicians.