Evaluation of the impact of the integrated management of neonatal and childhood illness strategy on neonatal and infant mortality in Haryana, India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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)
