Otieno Phelgona, Waiswa Peter, Butrick Elizabeth, Namazzi Gertrude, Achola Kevin, Santos Nicole, Keating Ryan, Lester Felicia, Walker Dilys
Kenya Medical Research Institute, Nairobi, Kenya.
Department of Health Policy, Planning and Management, Makerere University School of Public Health, Kampala, Uganda.
Trials. 2018 Jun 5;19(1):313. doi: 10.1186/s13063-018-2696-2.
Preterm birth (birth before 37 weeks of gestation) and its complications are the leading contributors to neonatal and under-5 mortality. The majority of neonatal deaths in Kenya and Uganda occur during the intrapartum and immediate postnatal period. This paper describes our study protocol for implementing and evaluating a package of facility-based interventions to improve care during this critical window.
METHODS/DESIGN: This is a pair-matched, cluster randomized controlled trial across 20 facilities in Eastern Uganda and Western Kenya. The intervention facilities receive four components: (1) strengthening of routine data collection and data use activities; (2) implementation of the WHO Safe Childbirth Checklist modified for preterm birth; (3) PRONTO simulation training and mentoring to strengthen intrapartum and immediate newborn care; and (4) support of quality improvement teams. The control facilities receive both data strengthening and introduction of the modified checklist. The primary outcome for this study is 28-day mortality rate among preterm infants. The denominator will include all live births and fresh stillbirths weighing greater than 1000 g and less than 2500 g; all live births and fresh stillbirths weighing between 2501 and 3000 g with a documented gestational age less than 37 weeks.
The results of this study will inform interventions to improve personnel and facility capacity to respond to preterm labor and delivery, as well as care for the preterm infant.
ClinicalTrials.gov, ID: NCT03112018 . Registered on 13 April 2017.
早产（妊娠37周前出生）及其并发症是新生儿和5岁以下儿童死亡的主要原因。肯尼亚和乌干达的大多数新生儿死亡发生在分娩期和产后即刻。本文描述了我们实施和评估一套基于机构的干预措施的研究方案，以改善这一关键时期的护理。
方法/设计：这是一项在乌干达东部和肯尼亚西部的20个机构进行的配对匹配、整群随机对照试验。干预机构接受四个组成部分：（1）加强常规数据收集和数据使用活动；（2）实施针对早产修改后的世界卫生组织安全分娩检查表；（3）PRONTO模拟培训和指导，以加强分娩期和新生儿即刻护理；（4）支持质量改进团队。对照机构接受数据强化和引入修改后的检查表。本研究的主要结局是早产儿的28天死亡率。分母将包括所有体重超过1000克且小于2500克的活产和新鲜死产；所有体重在2501至3000克之间且记录的孕周小于37周的活产和新鲜死产。
本研究结果将为改善应对早产和分娩以及护理早产儿的人员和机构能力的干预措施提供信息。
ClinicalTrials.gov，标识符：NCT03112018。于2017年4月13日注册。
