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
- 2
- 主要终点
- Post day 1 Neonatal mortality (birth to 28 days of age) 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.
详细描述
OBJECTIVES
The primary objective of this study is to determine the effectiveness of delivering community and facility based newborn interventions as part of the IMNCI strategy:
- in reducing (i) neonatal mortality beyond the first 24 hours of birth, i.e. from 1-28 days of age and (ii) overall neonatal mortality, i.e. from birth to 28 days of age, in the communities receiving the intervention [based on a cohort of infants born to women identified through pregnancy surveillance]
- in reducing (i) neonatal mortality beyond the first 24 hours of life (day 1-28) and (ii) overall neonatal mortality (birth to 28 days of age) in the population of newborns 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 [based on a cohort of infants born at home and available in the study area within 7 days of birth]
- in reducing infant mortality (from birth to 365 days of age) in the intervention communities [based on a cohort of infants born to women identified through pregnancy surveillance]
The secondary objectives of the study are to determine the effectiveness of delivering community and facility based newborn interventions as part of the IMNCI strategy:
- in improving newborn care practices in households.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
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 (birth to 28 days of age) in the communities receiving the intervention(cohort of infants born to women identified through pregnancy surveillance)
时间窗: Over 30 Months
Neonatal mortality (from birth to 28 days of age) in the cohort identified through pregnancy surveillance
时间窗: Over 30 Months
Post day 1 neonatal mortality (1 to 28 days of age) 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
Neonatal mortality (from birth to 28 days of age) in the population more likely to benefit from the intervention
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(Over 30 Months)
- Process of intervention delivery in a randomly selected subsample of activities(Over 30 Months)
研究者
NBhandari
Director
Society for Applied Studies