Burgoine Kathy, Ssenkusu John M, Nakiyemba Alice, Okello Francis, Napyo Agnes, Hagmann Cornelia, Namuyonga Judith, Hewitt-Smith Adam, Martha Muduwa, Loe Kate, Grace Abongo, Denis Amorut, Wandabwa Julius, Olupot-Olupot Peter
Mbale Clinical Research Institute (MCRI), Mbale, Uganda.
Makerere University School of Public Health, Kampala, Uganda.
Pilot Feasibility Stud. 2024 Oct 4;10(1):126. doi: 10.1186/s40814-024-01552-x.
Preterm birth is the leading cause of childhood mortality, and respiratory distress syndrome is the predominant cause of these deaths. Early continuous positive airway pressure is effective in high-resource settings, reducing the rate of continuous positive airway pressure failure, and the need for mechanical ventilation and surfactant. However, most deaths in preterm infants occur in low-resource settings without access to mechanical ventilation or surfactant. We hypothesize that in such settings, early continuous positive airway pressure will reduce the rate of failure and therefore preterm mortality.
This is a mixed methods feasibility and acceptability, single-center pilot randomized control trial of early continuous positive airway pressure among infants with birthweight 800-1500 g. There are two parallel arms: (i) application of continuous positive airway pressure; with optional oxygen when indicated; applied in the delivery room within 15 min of birth; transitioning to bubble continuous positive airway pressure after admission to the neonatal unit if Downes Score ≥ 4 (intervention), (ii) supplementary oxygen at delivery when indicated; transitioning to bubble continuous positive airways pressure after admission to the neonatal unit if Downes Score ≥ 4 (control). A two-stage consent process (verbal consent during labor, followed by full written consent within 24 h of birth) and a low-cost third-party allocation process for randomization will be piloted. We will use focus group discussions and key informant interviews to explore the acceptability of the intervention, two-stage consent process, and trial design. We will interview healthcare workers, mothers, and caregivers of preterm infants. Feasibility will be assessed by the proportion of infants randomized within 15 min of delivery; the proportion of infants in the intervention arm receiving CPAP within 15 min of delivery; and the proportion of infants with primary and secondary outcomes measured successfully.
This pilot trial will enhance our understanding of methods and techniques that can enable emergency neonatal research to be carried out effectively, affordably, and acceptably in low-resource settings. This mixed-methods approach will allow a comprehensive exploration of parental and healthcare worker perceptions, experiences, and acceptance of the intervention and trial design.
The study is registered on the Pan African Clinical Trials Registry (PACTR) PACTR202208462613789. Registered 08 August 2022. https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=23888 .
早产是儿童死亡的主要原因，而呼吸窘迫综合征是这些死亡的主要原因。早期持续气道正压通气在资源丰富的环境中有效，可降低持续气道正压通气失败率、机械通气需求和表面活性剂需求。然而，大多数早产儿死亡发生在无法获得机械通气或表面活性剂的资源匮乏地区。我们假设，在这种环境下，早期持续气道正压通气将降低失败率，从而降低早产死亡率。
这是一项关于出生体重800 - 1500克婴儿早期持续气道正压通气的混合方法可行性和可接受性单中心试点随机对照试验。有两个平行组：（i）持续气道正压通气的应用；必要时可选择吸氧；出生后15分钟内在产房应用；如果唐斯评分≥4，进入新生儿病房后转为气泡式持续气道正压通气（干预组），（ii）必要时在分娩时补充氧气；如果唐斯评分≥4，进入新生儿病房后转为气泡式持续气道正压通气（对照组）。将试点两阶段同意程序（分娩时口头同意，随后在出生后24小时内签署完整书面同意书）和低成本第三方随机分配程序。我们将使用焦点小组讨论和关键信息提供者访谈来探讨干预措施、两阶段同意程序和试验设计的可接受性。我们将采访医护人员、母亲和早产儿护理人员。可行性将通过分娩后15分钟内随机分组的婴儿比例、干预组中分娩后15分钟内接受持续气道正压通气的婴儿比例以及成功测量主要和次要结局的婴儿比例来评估。
这项试点试验将增进我们对能够在资源匮乏地区有效、经济且可接受地开展新生儿急诊研究的方法和技术的理解。这种混合方法将全面探索父母和医护人员对干预措施和试验设计的看法、经验及接受程度。
该研究已在泛非临床试验注册中心（PACTR）注册，注册号为PACTR202208462613789。于2022年8月8日注册。https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=23888 。
