Summary of ongoing randomised clinical trials about NHFOV in neonates
| Country | Status (cause) | Patients | Control arm | Primary outcome | Secondary outcomes | Identifier |
|---|---|---|---|---|---|---|
| China | Not yet recruiting | >28 weeks; postextubation | NIPPV | Intubation rate | Apnoea, air leaks, BPD, NEC incidence | NCT02543125 |
| Canada | Suspended (poor recruitment) | <28 weeks; postextubation | CPAP | Intubation rate | PaCO2, air leaks, IVH, feeding intolerance | NCT01852916 |
| Germany | Recruiting | <32 weeks; postextubation | CPAP | PaCO2 | Other gas exchange measures, intubation rate, IVH, BPD, NEC | NCT02340299 |
| Canada | Recruiting | <1250 g; >72 hours of life; failing postextubation CPAP | BiPAP | Failure of NHFOV/BiPAP | Intubation rate, ventilation length, PaCO2, NICU stay, IVH, BPD, apnoeic spells, common adverse outcomes | NCT02051491 |
Search has been conducted using ‘NHFOV’ or ‘HFOV’ and ‘non-invasive’ or ‘NHFIV’ as keywords in ClinicalTrial.gov, IRSCTN Registry and in the Australian-New Zealand Clinical Trials Registry (as per 7 February 2015). All trials have been registered only in ClinicalTrial.gov.
BiPAP, biphasic positive airway pressure; BPD, bronchopulmonary dysplasia; CPAP, continuous positive airway pressure; IVH, intraventricular haemorrhage; NEC, necrotising enterocolitis; NHFOV, non-invasive high-frequency oscillatory ventilation; NICU, neonatal intensive care unit; NIPPV, non-invasive positive pressure ventilation.