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临床试验/NCT03665012
NCT03665012已完成不适用

The Pediatric Development Clinic Study: the Development, Medical and Nutritional Outcomes of Children Discharged From the Neonatal Unit in Rural Rwanda

Partners in Health1 个研究点 分布在 1 个国家目标入组 376 人开始时间: 2017年4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
376
试验地点
1
主要终点
To compare developmental outcomes of children who were enrolled in the PDC to children who did not receive PDC services and to the general population.

研究概览

简要总结

Many preterm, low birth weight and other high-risk infants are surviving the early neonatal period. However, upon discharge from the neonatal units, this at-risk population has little support for their health, nutrition and development in the community. To address this emerging need, Partners In Health in collaboration with the Ministry of Health and UNICEF, has created a pediatric developmental clinic (PDC) to follow the high-risk infants after discharge from hospitals and health centers.

详细描述

Neonatal health and improving neonatal mortality has become one of the top priorities globally. In Rwanda, hospital care has advanced significantly with the development of national neonatal care guidelines and widespread provider training. As advances in technology and resuscitation become more commonly available, many preterm, low birth weight and other high-risk infants are surviving the early neonatal period. However, upon discharge from the neonatal units, this at-risk population has little support for their health, nutrition and development in the community. To address this emerging need, Partners In Health in collaboration with the Ministry of Health and UNICEF, has created a pediatric developmental clinic (PDC) to follow the high-risk infants after discharge from hospitals and health centers. Prior to implementation, a community-based descriptive study assessing the baseline medical, nutritional and developmental needs of low-birth weight and preterm infants who are the target population of the pediatric development clinic was conducted (Baseline Phase One). Subsequently, after 1-2 years of implementation an evaluation of clinical, nutritional and developmental outcomes of children followed in PDC will be conducted in comparison with the baseline study outcomes (Post-PDC Phase Two). Ongoing research on PDC implementation will focus on research on patient and provider experiences, overall clinic processes, cost-effectiveness, expansion of the PDC model, decentralization to health centers, and longer term outcomes of children enrolled in the PDC to further help refine the PDC model (Post-PDC Phase Three)

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
1 Week 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All under-five children meeting PDC referral criteria as described in the study population description will be enrolled in PDC.

排除标准

  • Patients who do not meet referral criterial for PDC or who are over age 5 years.

结局指标

主要结局

To compare developmental outcomes of children who were enrolled in the PDC to children who did not receive PDC services and to the general population.

时间窗: April 2014 to March 2019

Proportion of children who are on track developmentally measured by the Ages and Stages Questionnaire Version 3 (ASQ-3) and Caregiver Reported Early Childhood Development Index (CREDI).

次要结局

  • To compare nutritional outcomes of children who were enrolled in the PDC to children who did not receive PDC services and to the general population.(April 2014 to March 2019)

研究者

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

Catherine Kirk

Director of Maternal and Child Health

Partners in Health

研究点 (1)

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