Impact of prophylactic CPAP in the delivery room (DR-CPAP) on neonates <1500g in a low-resource setting: A feasibility trial

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A birth that occurs before the start of the 37th week of pregnancy is termed a preterm birth. Complications of preterm births are the leading cause of under-five deaths worldwide. Inadequate lung development is a common and serious complication in preterm births, and is believed to be the leading cause of these preterm deaths. The highest risk of inadequate lung development is in infants born <1500g, termed very low birthweight (VLBW) infants. Unfortunately there are limited treatments available for inadequate lung development in low-resource settings. A number of studies have shown that simple and low-cost breathing support called bubble continuous positive airways pressure (bCPAP) can be safely and effectively implemented in low-resource settings. Indeed, we have shown a 44% reduction in preterm mortality in VLBW infants in our neonatal unit in Uganda following the implementation of bCPAP (Okello et al., 2019). Currently, there are no definitive studies and no consensus on the ideal time to start CPAP in preterms neonates in low-resource settings. In high-income countries (HICs), early CPAP has been shown to reduce the need for mechanical ventilation and artificial lung surfactant, neither of which are available in low-resources settings leaving the preterm neonates with no further options for treatment. It is our belief, that early prophylactic CPAP in the delivery room in a low-resource setting is feasible, acceptable and safe and has the potential to reduce preterm mortality substantially. The feasibility of initiating CPAP in the delivery room has never been studied in a LIC. This pilot study is designed to determine the feasibility and acceptability of initiating CPAP in VLBW infants in the delivery room (DR-CPAP). It will also evaluate the safety of DR-CPAP in this setting through monitoring the number and nature of any adverse events. It will also determine the feasibility of randomizing VLBW infants within 15 minutes of birth to receive either DR-CPAP or to receive standard CPAP in the neonatal unit when clinically indicated. This pilot study will also evaluate the acceptability of using deferred consent in the delivery room for neonatal emergencies in this setting. Together these results will provide important data and knowledge to inform the design of a future larger multi-centre trial that will evaluate the impact of DR-CPAP on mortality and morbidity in VLBW infants.