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Community health and medical provision: impact on neonates

Community Health And Medical Provision: Impact On Neonates (CHAMPION)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN24104646
Enrollment
Unknown
Registered
2007-03-20
Start date
2007-09-01
Completion date
Unknown
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal mortality Neonatal Diseases Neonatal mortality

Interventions

Unblinded cluster-randomised controlled trial involving 464 villages, with the village as the unit of randomisation A multi-level program: community health promotion and contracting out primary and s

Sponsors

Effective Intervention (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The trial site is the Nagarkurnool division of Mahabubnagar district in the Indian state of Andhra Pradesh. The trial will involve only those villages in the division with a population of less than 2,500 people. A woman is eligible for inclusion in the trial if she satisfies the following criteria: she is married, less than 50 years old, and resident in one of the 464 villages at the time of a baseline survey that is to be carried out immediately prior to randomization. Once the baseline survey has been carried out and the eligible women listed, the only permitted addition to the trial will be those women who marry into a trial village. Women will not be added or removed from the list as a result of either temporary or permanent migration from the village in which they are initially registered. Only those children of eligible women whose estimated date of delivery at enumeration is at least six months after randomization will be included in the trial. As training and establishment of services in intervention villages will require time to be achieved, this lag in measurement is necessary to ensure exposure to the intervention.

Exclusion criteria

Exclusion criteria: Women and their children will be excluded from the trial if the woman in question is unmarried, if she is aged 50 or over at the time of the baseline survey or if she refuses to participate in the baseline survey.

Design outcomes

Primary

MeasureTime frame
Neonatal mortality

Secondary

MeasureTime frame
1. Neonatal death 2. Neonatal morbidity 3. Maternal mortality and morbidity 4. Health service usage 5. Costs and several process 6. Knowledge outcomes

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026