Effect of a quality improvement package for intrapartum and immediate newborn care on fresh stillbirth and neonatal mortality among preterm and low-birthweight babies in Kenya and Uganda: a cluster-randomised facility-based trial.
Effect of a quality improvement package for intrapartum and immediate newborn care on fresh stillbirth and neonatal mortality among preterm and low-birthweight babies in Kenya and Uganda: a cluster-randomised facility-based trial.
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DOI：
10.1016/s2214-109x(20)30232-1
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发表时间：
2020-08-01
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影响因子：
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通讯作者：
Waiswa, Peter
中科院分区：
文献类型：
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作者：
Walker, Dilys;Otieno, Phelgona;Waiswa, Peter
背景技术背景：虽然许多低收入和中等收入国家的新生儿存活率有所提高，但死产和新生儿死亡率的下降速度缓慢。早产并发症是死产和新生儿死亡的主要原因。我们的目的是评估一个质量改进包产时和立即新生儿护理死产和早产新生儿存活率在肯尼亚和乌干达，在循证医学的做法往往underutilized.METHODS：这揭盲集群随机对照试验是在肯尼亚西部和乌干达东部的设施，提供24小时的孕产妇保健，每年至少有200出生。该研究评估了低出生体重和早产儿的结果。符合条件的设施配对，并随机分配（1：1）到干预组或对照组。所有设施都得到了加强产妇登记数据和修订的世卫组织安全分娩清单;干预组的设施还接受了使用PRONTO模拟和团队培训以及质量改进协作的提供者指导。体重在1000 g至2500 g之间或小于3000 g且记录的胎龄小于37周的活产或新鲜死产婴儿纳入分析。我们从产妇登记册中提取了产妇和分娩结果的数据。通过电话或亲自进行随访，以确定婴儿在28天时的状态。主要结局为新鲜死胎和28天新生儿死亡率。该试验在ClinicalTrials.gov注册，NCT 03112018。结果：2016年10月1日至2019年4月30日期间，20家设施被随机分配到干预组（n=10）或对照组（n=10）。在这些设施的5343名合格婴儿中，我们评估了2938名新生儿和新鲜死产婴儿的结局（干预组1447名，对照组1491名）。对照组1491名婴儿中有347名（23%）死产或在新生儿期死亡，而干预组1447名婴儿中有221名（15%）在28天时死亡（比值比0.66，95%CI 0.54 - 0.81）。没有发现任何伤害或不良影响。解释：低出生体重和早产儿中的新鲜死产和新生儿死亡率可以通过一揽子干预措施来降低，这些干预措施加强了以证据为基础的实践，并投资于卫生系统的加强。
BACKGROUND: Although gains in newborn survival have been achieved in many low-income and middle-income countries, reductions in stillbirth and neonatal mortality have been slow. Prematurity complications are a major driver of stillbirth and neonatal mortality. We aimed to assess the effect of a quality improvement package for intrapartum and immediate newborn care on stillbirth and preterm neonatal survival in Kenya and Uganda, where evidence-based practices are often underutilised.METHODS: This unblinded cluster-randomised controlled trial was done in western Kenya and eastern Uganda at facilities that provide 24-h maternity care with at least 200 births per year. The study assessed outcomes of low-birthweight and preterm babies. Eligible facilities were pair-matched and randomly assigned (1:1) into either the intervention group or the control group. All facilities received maternity register data strengthening and a modified WHO Safe Childbirth Checklist; facilities in the intervention group additionally received provider mentoring using PRONTO simulation and team training as well as quality improvement collaboratives. Liveborn or fresh stillborn babies who weighed between 1000 g and 2500 g, or less than 3000 g with a recorded gestational age of less than 37 weeks, were included in the analysis. We abstracted data from maternity registers for maternal and birth outcomes. Follow-up was done by phone or in person to identify the status of the infant at 28 days. The primary outcome was fresh stillbirth and 28-day neonatal mortality. This trial is registered with ClinicalTrials.gov, NCT03112018.FINDINGS: Between Oct 1, 2016, and April 30, 2019, 20 facilities were randomly assigned to either the intervention group (n=10) or the control group (n=10). Among 5343 eligible babies in these facilities, we assessed outcomes of 2938 newborn and fresh stillborn babies (1447 in the intervention and 1491 in the control group). 347 (23%) of 1491 infants in the control group were stillborn or died in the neonatal period compared with 221 (15%) of 1447 infants in the intervention group at 28 days (odds ratio 0·66, 95% CI 0·54-0·81). No harm or adverse effects were found.INTERPRETATION: Fresh stillbirth and neonatal mortality among low-birthweight and preterm babies can be decreased using a package of interventions that reinforces evidence-based practices and invests in health system strengthening.FUNDING: Bill & Melinda Gates Foundation.