Impact of prophylactic CPAP in the delivery room (DR-CPAP) on neonates <1500g in a low-resource setting: A feasibility trial
Medical Research Council
Mbale Clinical Research Institute
Complications of prematurity are the leading cause of deaths in children under the age of five and the majority occur in low income countries. The predominant reason for these preterm deaths is respiratory distress syndrome (RDS). In high-income countries (HICs), the use of early CPAP, within 15 minutes of delivery, can reduce the need for mechanical ventilation and surfactant in the treatment of RDS. In low-resource settings, where access to mechanical ventilation or artificial surfactant is limited, when CPAP fails there are limited options for care. We hypothesise that initiation of early prophylactic CPAP in the delivery room (DR-CPAP) will reduce the rate of CPAP failure and therefore the neonatal mortality rate in low-resource settings. This project will develop and test for feasibility, acceptability and safety a protocol for DR-CPAP, which if successful can later be tested for efficacy in a future trial. The feasibility of initiating CPAP in VLBW neonates within 15 minutes of delivery in this low-resource setting will be evaluated. The acceptability of administering CPAP in the delivery room will be assessed. The safety of DR-CPAP will be evaluated through adverse events. This project will ensure that deferred consent with prior assent is acceptable to both the mothers and the medical staff for a trial of neonatal emergency care. We will pilot low-cost third party randomisation and assess if neonates can randomised within 15 minutes of delivery to allow initiation of DR-CPAP within a suitable timeframe. This study will validate secondary outcomes for the future trial. The strong involvement of health leaders, medical staff, and mothers at all stages will ensure that if successful, the intervention will be both acceptable to the communities and more effectively scaled-up. Together these findings will allow us to design a large and robust multi-centre unblinded randomised controlled trial to evaluate the impact of DR-CPAP on mortality in VLBW infants.
6.3 Medical devices / Research Grant