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临床试验/CTRI/2009/091/000715
CTRI/2009/091/000715已完成不适用

Evaluation of the impact of the integrated management of neonatal and childhood illness strategy on neonatal and infant mortality in Haryana, India

Nita Bhandari1 个研究点 分布在 1 个国家目标入组 66,600 人开始时间: 2008年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
Nita Bhandari
入组人数
66,600
试验地点
1
主要终点
POST DAY 1 NEONATAL MORTALITY and NEONATAL MORTALITY in the communities receiving the intervention (cohort of infants born to women identified through pregnancy surveillance)

研究概览

简要总结

This study is a cluster-randomized trial being conducted in the state of Haryana in North India. Eighteen geographical areas served by Primary Health Centres (PHCs) have been randomized to intervention or comparison areas. In the intervention areas, all physicians, health workers and ICDS workers are being trained in the IMNCI. Each of these clusters has an approximate population of 30,000.The IMNCI intervention includes three main components:improvement in the case management skills of health staff improvement in the overall health system to support its performance, and improvement in family and community health care practices which include:prevention and management of hypothermia early initiation of breastfeeding and exclusive breastfeeding community-based care of low birth weight infants improved care-seeking for neonatal infections The primary outcome measures of the study are neonatal and infant mortality. The study will also collect information on cause-specific neonatal mortality, ascertained using a standardized previously validated verbal autopsy instrument administered by trained, skilled health workers. All the other outcomes (including initiation of breastfeeding within 1 hour of birth; Exclusive breastfeeding at 4 weeks of age; Proportion of neonates identified to be sick by caregivers who sought care) are secondary outcomes.The effectiveness of this comprehensive intervention will be measured by comparing the primary and secondary outcome measures in the intervention and comparison clusters, controlling for any baseline differences such as the predefined outcomes and/or socioeconomic status and demography.The project will serve as a guide to the Government of India of how to best implement the IMNCI strategy and measure its impact.

研究设计

研究类型
Interventional
分配方式
Stratified randomization
盲法
Open Label

入排标准

年龄范围
0.00 Day(s) 至 12.00 Month(s)(—)
性别
All

入选标准

  • All births.

排除标准

  • 未提供

结局指标

主要结局

POST DAY 1 NEONATAL MORTALITY and NEONATAL MORTALITY in the communities receiving the intervention (cohort of infants born to women identified through pregnancy surveillance)

时间窗: 30 months

POST DAY 1 NEONATAL MORTALITY and NEONATAL MORTALITY in the population of newborns who are more likely to have greater impact from the intervention i.e. those born at home and available in the study area within 7 days of birth

时间窗: 30 months

INFANT MORTALITY (birth to 365 days) in the communities receiving the intervention

时间窗: 30 months

次要结局

  • Population coverage of key behaviours and interventions(30 months)
  • Process of intervention delivery in a randomly selected subsample of activities(30 months)

研究者

发起方
Nita Bhandari
申办方类型
Research institution

研究点 (1)

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