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

在怀孕第37周开始之前的分娩被称为早产。早产并发症是全球五岁以下儿童死亡的主要原因。肺发育不足是早产常见的严重并发症，被认为是早产死亡的主要原因。肺发育不全的风险最高的是出生体重小于1500克的婴儿，被称为极低出生体重(VLBW)婴儿。不幸的是，在资源匮乏的环境中，针对肺发育不足的治疗方法有限。许多研究表明，被称为气泡持续正压(BCPAP)的简单、低成本的呼吸支持可以在低资源环境下安全有效地实施。事实上，我们已经显示，在实施bCPAP后，我们乌干达新生儿病房的极低出生体重儿的早产死亡率降低了44%(Okello等人，2019年)。目前，在资源匮乏的环境中，对早产儿开始CPAP的理想时间没有明确的研究，也没有共识。在高收入国家，早期CPAP已被证明可以减少对机械通风和人工肺表面活性物质的需求，在资源匮乏的情况下，这两种方法都不存在，使早产儿没有进一步的治疗选择。我们认为，在低资源环境下的产房早期预防性CPAP是可行的、可接受的和安全的，并有可能大幅降低早产死亡率。在产房启动CPAP的可行性从未在LIC中被研究过。这项先导性研究旨在确定在产房内对极低出生体重儿(DR-CPAP)启动CPAP的可行性和可接受性。它还将通过监测任何不良事件的数量和性质来评估DR-CPAP在这种情况下的安全性。它还将确定在出生后15分钟内随机安排极低出生体重儿接受DR-CPAP或在临床指示时在新生儿病房接受标准CPAP的可行性。这项先导性研究还将评估在这种情况下在产房中对新生儿紧急情况使用延期同意的可接受性。总之，这些结果将提供重要的数据和知识，为未来更大规模的多中心试验的设计提供信息，该试验将评估DR-CPAP对极低出生体重儿死亡率和发病率的影响。

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.