背景:印度农村地区新生儿死亡率高,识字和算术能力低。我们评估了一套复杂的健康干预措施对新生儿生存的影响,以及在中央邦农村开展课外教学对儿童识字和算术能力的影响。
方法:这是一项集群随机对照试验,村庄(集群)接受健康(CHAMPION2)或教育(STRIPES2)干预。在早期冠军/条纹试验的设计基础上,接受健康干预的村庄是教育干预的对照,反之亦然。集群是Satna区的196个村庄,中央邦,印度:每个距离社区卫生中心至少5公里,人口低于2500,至少有15名儿童有资格接受教育干预。CHAMPION2的参与者是年龄小于50岁的已婚妇女,他们没有进行过计划生育手术,只要他们是随机化前列举的或与随机化前列举的男性结婚。STRIPES2的参与者是2010年6月16日至2013年6月15日出生的居民儿童,在2018-2019学年之前不在学校,并打算在2018-2019或2019-2020年注册一年级。
结论:在CHAMPION2中,NICE基金会将提供一项为期3.5年的计划,其中包括经过认证的社会健康活动家或乡村卫生工作者和助产士,产后,和新生儿保健;社区动员;转诊到适当的政府卫生设施;以及健康教育运动。在STRIPES2,普拉瑟姆教育基金会将提供一个基于村庄的计划,课前/课后支持,重点关注识字和算术。作为控制,2个CHAMPION2控制村庄将获得通常的医疗服务(加上STRIPES2干预)。STRIPES2控制村庄将获得通常的教育服务(加上CHAMPION2干预)。CHAMPION2的主要结局是新生儿死亡率。次要结果包括产前,delivery,新生儿和产后即时护理实践,孕产妇死亡率,死产,新生儿早期死亡,围产期死亡,健康知识,入院,母亲输血,和成本效益。STRIPES2中的主要结果是综合识字和算术测试得分。次要结果包括单独的识字和算术分数,报告入学率和出勤率,父母参与孩子的学习,和成本效益。独立的研究和实施小组将进行试验。试验指导和数据监测委员会,有独立成员,将监督审判。
背景:印度临床试验注册:CTRI/2019/05/019296。2019年5月23日注册。http://www。ctri.nic.in/临床试验/pdf_generate.php?trialid=31198&EncHid=&modid=&compid=%27,%2731198det%27。
BACKGROUND: Rural areas of India exhibit high neonatal mortality, and low literacy and numeracy. We assess the effect of a complex package of health interventions on neonatal survival and the effect of out-of-school-hours teaching on children\'s literacy and numeracy in rural Madhya Pradesh.
METHODS: This is a cluster-randomised controlled trial with villages (clusters) receiving either a health (CHAMPION2) or education (STRIPES2) intervention. Building on the design of the earlier CHAMPION/STRIPES trial, villages receiving the health intervention are controls for the education intervention and vice versa. The clusters are 196 villages in Satna district, Madhya Pradesh, India: each is at least 5 km from a Community Health Centre, has a population below 2500, and has at least 15 children eligible for the education intervention. The participants in CHAMPION2 are resident married women younger than 50 years of age who had not undergone a family planning operation, provided they are enumerated pre-randomisation or marry a man enumerated pre-randomisation. The participants in STRIPES2 are resident children born 16 June 2010 to 15 June 2013, not in school before the 2018-2019 school year and intending to enrol in first grade in 2018-2019 or 2019-2020.
CONCLUSIONS: In CHAMPION2, the NICE Foundation will deliver a 3.5-year programme comprising Accredited Social Health Activists or village health workers and midwives promoting health knowledge and providing antenatal, postnatal, and neonatal healthcare; community mobilisation; referrals to appropriate government health facilities; and a health education campaign. In STRIPES2, the Pratham Education Foundation will deliver a programme of village-based, before/after school support focusing on literacy and numeracy. As controls, the CHAMPION2 control villages will receive the usual health services (plus the STRIPES2 intervention). STRIPES2 control villages will receive the usual education services (plus the CHAMPION2 intervention). The primary outcome in CHAMPION2 is neonatal mortality. Secondary outcomes include antenatal, delivery, immediate neonatal and postnatal care practices, maternal mortality, stillbirths, early neonatal deaths, perinatal deaths, health knowledge, hospital admissions, maternal blood transfusions, and cost effectiveness. The primary outcome in STRIPES2 is a composite literacy and numeracy test score. Secondary outcomes include separate literacy and numeracy scores, reported school enrolment and attendance, parents\' engagement with children\'s learning, and cost effectiveness. Independent research and implementation teams will conduct the trial. Trial Steering and Data Monitoring Committees, with independent members, will supervise the trial.
BACKGROUND: Clinical Trial Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=31198&EncHid=&modid=&compid=%27,%2731198det%27.