London School of Hygiene and Tropical Medicine, London, UK.
Effective Intervention, London, UK.
Trials. 2024 Apr 25;25(1):280. doi: 10.1186/s13063-024-08056-2.
Neonatal mortality in India has fallen steadily and was estimated to be 24 per 1000 live births in the year 2017. However, neonatal mortality remains high in rural parts of the country. The Community Health Promotion and Medical Provision and Impact On Neonates (CHAMPION2) trial investigates the effect of a complex health intervention on neonatal mortality in the Satna District of Madhya Pradesh.
METHODS/DESIGN: The CHAMPION2 trial forms one part of a cluster-randomised controlled trial with villages (clusters) randomised to receive either a health (CHAMPION2) or education (STRIPES2) intervention. Villages receiving the health intervention are controls for the education intervention and vice versa. The primary outcome is neonatal mortality. The effect of the active intervention on the primary outcome (compared to usual care) will be expressed as a risk ratio, estimated using a generalised estimating equation approach with robust standard errors that take account of clustering at village level. Secondary outcomes include maternal mortality, stillbirths, perinatal deaths, causes of death, health care and knowledge, hospital admissions of enrolled women during pregnancy or in the immediate post-natal care period or of their babies (during the neonatal period), maternal blood transfusions, and the cost effectiveness of the intervention. A total of 196 villages have been randomised and over 34,000 women have been recruited in CHAMPION2.
This update to the published trial protocol gives a detailed plan for the statistical analysis of the CHAMPION2 trial.
Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzExOTg=&Enc=&userName=champion2.
印度的新生儿死亡率稳步下降，据估计，2017 年每 1000 例活产中有 24 例死亡。然而，该国农村地区的新生儿死亡率仍然很高。社区健康促进和医疗供应及对新生儿的影响（CHAMPION2）试验调查了一种复杂的健康干预措施对中央邦萨塔纳区新生儿死亡率的影响。
方法/设计：CHAMPION2 试验是一项整群随机对照试验的一部分，将村庄（群）随机分为接受健康（CHAMPION2）或教育（STRIPES2）干预组。接受健康干预的村庄是教育干预的对照组，反之亦然。主要结局是新生儿死亡率。使用广义估计方程方法和稳健标准误差来估计活性干预对主要结局（与常规护理相比）的效果，该方法考虑了村级聚类。次要结局包括孕产妇死亡率、死产、围产期死亡、死因、卫生保健和知识、孕妇在怀孕期间或产后立即住院或其婴儿（在新生儿期）住院、产妇输血，以及干预的成本效益。共有 196 个村庄被随机分组，CHAMPION2 共招募了超过 34000 名妇女。
本试验方案的更新提供了 CHAMPION2 试验的详细统计分析计划。
印度注册处：CTRI/2019/05/019296。于 2019 年 5 月 23 日注册。https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzExOTg=&Enc=&userName=champion2。
