Contact information
Type
Scientific
Primary contact
Dr Peter Boone
ORCID ID
Contact details
Effective Intervention
Room R430
Centre for Economic Performance
London School of Economics
Houghton Street
London
WC2A 2AE
United Kingdom
+44 (0)20 7955 7408
peterboone@effectiveintervention.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1.0, 05/02/07
Study information
Scientific title
Community Health And Medical Provision: Impact On Neonates (CHAMPION)
Acronym
CHAMPION
Study hypothesis
Neonatal mortality rates in India are high compared to other low income countries, and there is a wide variation of rates across regions. One area with a particularly high rate is Mahabubnagar District in the state of Andhra Pradesh, where neonatal mortality is estimated to be in the region of 4-9%. The area suffers from a vicious cycle of both poor supply of and small demand for health care services.
Neonatal mortality can be reduced through systemic changes to the provision and promotion of health care.
Ethics approval
Institutional Review Board of the L.V. Prasad Eye Institute, Hyderabad, India, ref: LEC07002 - approval pending
Study design
Unblinded cluster-randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Neonatal mortality
Intervention
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 secondary health services to non-public providers. The health promotion campaign will include a health education campaign, participatory discussion groups, training of village health workers and midwives, and improved coordination of antenatal services. These services will be provided for free to pregnant women and neonates in the intervention communities. The intervention group will also have subsidised access to primary and secondary pregnancy-related health care services at non-public health centres.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Neonatal mortality
Secondary outcome measures
1. Neonatal death
2. Neonatal morbidity
3. Maternal mortality and morbidity
4. Health service usage
5. Costs and several process
6. Knowledge outcomes
Overall trial start date
01/09/2007
Overall trial end date
01/01/2011
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
464 villages
Participant 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.
Recruitment start date
01/09/2007
Recruitment end date
01/01/2011
Locations
Countries of recruitment
India
Trial participating centre
Effective Intervention
London
WC2A 2AE
United Kingdom
Sponsor information
Organisation
Effective Intervention (UK)
Sponsor details
c/o Dr Peter Boone
Room R430
Centre for Economic Performance
London School of Economics
Houghton Street
London
WC2A 2AE
United Kingdom
+44 (0) 20 7955 7408
peterboone@effectiveintervention.com
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Effective Intervention in the Centre for Economic Performance at the London School of Economics (UK registered charity no. 1111709) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Naandi Foundation (India trust registration number 1745/98) (India)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28678849