The use of low flow nasal prongs therapy versus self ventilation in weaning neonates from nasal continuous positive airway pressure (NCPAP). The NOFLO trial

Background and aims At present there is only anecdotal evidence to commence very low birth weight infants (VLBWI, less than 1500g) on low flow nasal prongs therapy (less than 2l/min) using room air when weaning from nCPAP. However this practice remains routine in many neonatal centres. The primary aim of the study was to determine if an improved outcome could be observed in using low flow nasal prongs therapy when weaning VLBWI from nCPAP, compared to self ventilation. Methods This was a multi-centre, randomised controlled trial conducted between February 2010 and April 2011. VLBWI receiving ventilatory support for a minimum of 48 hours and who were stable on nCPAP for 24 hours on minimal settings were eligible for enrolment into this study. Exclusion criteria included any congenital, respiratory or cardiac abnormality at the time of weaning from nCPAP. The neonates were randomised into two groups; an intervention group which used low flow nasal prongs therapy without oxygen on weaning from nCPAP, and a control group which were assigned to self ventilation on weaning from nCPAP. The patients were monitored for 5 consecutive days following randomisation and the primary outcome measure was weaning failure rate. It was estimated that 50% of infants, if randomised to self ventilation, would fail the weaning process based on a retrospective chart review. It was then calculated that 78 babies would be required to establish an absolute difference of 30% (80% power and alpha of 5%). We used intention to treat analysis. Results Seventy eight infants were randomised (39 to nasal prongs versus 39 to self ventilation) Both groups were similar for birth weight and gestational age and also for weight and corrected gestational age at the time of randomisation. 17 infants (44%) in nasal prongs therapy group failed the weaning process versus 12 infants (31%) in the self ventilation therapy group. There was no statistically significant difference between the two groups in failure rate (OR 1.74, 95% CI 0.7 to 4.4, p=0.35). Conclusions There is no advantage to using nasal prongs with room air compared to self ventilation when weaning VLBWI from nCPAP.