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临床试验/NCT03923023
NCT03923023已完成不适用

Preterm Resources, Education, and Effective Management for Infants

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 11,195 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11,195
试验地点
2
主要终点
10% relative risk reduction in 28-day neonatal mortality rate in preterm infants

研究概览

简要总结

The purpose of this Quality Improvement initiative is to reduce severe morbidity and mortality among premature infants through proven and cost-effective clinical management during the antenatal, intrapartum, and postpartum periods. In order to reduce neonatal mortality and morbidity due to preterm birth complications, health facilities must be able to identify and manage women in preterm labor, accurately administer medications, and provide high-quality postnatal care.

详细描述

The purpose of this Quality Improvement initiative is to reduce severe morbidity and mortality among premature infants through proven and cost-effective clinical management during the antenatal, intrapartum, and postpartum periods. In order to reduce neonatal mortality and morbidity due to preterm birth complications, health facilities must be able to identify and manage women in preterm labor, accurately administer medications, and provide high-quality postnatal care.

The study will provide evidence of implementing a package of clinical interventions coupled with quality improvement and monitoring strategy aimed at reducing neonatal mortality in 3 resource-limited health facilities, leveraging on an existing strengthened birth registry to provide neonatal outcomes up to 28 days after delivery. Additionally, using a multifaceted approach through an interdisciplinary team, the investigators will identify the social and cultural barriers that contribute to home-based deliveries. These findings will be helpful to the Ministry of Health in shaping future policies regarding the scale-up of newborn care clinical protocols as part of Government's efforts to reducing neonatal mortality in Zambia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women who seek Antenatal care services and plan to deliver in the selected health facilities
  • Women who reside within the larger catchment area of the selected 3 health facilities

排除标准

  • Women who reside outside the larger catchment area of the health facilities
  • Women who have not sought antenatal care services in the 3 health facilities and have come to only deliver there

结局指标

主要结局

10% relative risk reduction in 28-day neonatal mortality rate in preterm infants

时间窗: Baseline to 36 months

Rate of 28-day neonatal mortality at the end of the study compared to that at baseline

次要结局

  • 20% relative risk reduction in all-cause 7-day neonatal mortality in preterm infants(Baseline to 36 months)
  • Factors that contribute to home and facility deliveries within the PREEMI facility catchment areas through the use of pre-determined questionnaire.(Baseline to 36 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Albert Manasyan

Assistant Professor

University of Alabama at Birmingham

研究点 (2)

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