Community health and medical provision: impact on neonates

ISRCTN	ISRCTN24104646
DOI	https://doi.org/10.1186/ISRCTN24104646
Secondary identifying numbers	Version 1.0, 05/02/07

Submission date: 07/02/2007
Registration date: 20/03/2007
Last edited: 06/07/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Peter Boone
Scientific

Effective Intervention
Room R430
Centre for Economic Performance
London School of Economics
Houghton Street
London
WC2A 2AE
United Kingdom

Phone	+44 (0)20 7955 7408
Email	peterboone@effectiveintervention.com

Study information

Study design	Unblinded cluster-randomised controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Community
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Community Health And Medical Provision: Impact On Neonates (CHAMPION)
Study acronym	CHAMPION
Study objectives	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(s)	Institutional Review Board of the L.V. Prasad Eye Institute, Hyderabad, India, ref: LEC07002 - approval pending
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/09/2007
Completion date	01/01/2011

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	464 villages
Key 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.
Key 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.
Date of first enrolment	01/09/2007
Date of final enrolment	01/01/2011

Locations

Countries of recruitment

England
India
United Kingdom

Study participating centre

Effective Intervention

London
WC2A 2AE
United Kingdom

Sponsor information

Effective Intervention (UK)
Charity

c/o Dr Peter Boone
Room R430
Centre for Economic Performance
London School of Economics
Houghton Street
London
WC2A 2AE
United Kingdom

Phone	+44 (0) 20 7955 7408
Email	peterboone@effectiveintervention.com
Website	http://www.effint.org/
"ROR"	https://ror.org/00a1wp308

Funders

Funder type

Charity

Effective Intervention in the Centre for Economic Performance at the London School of Economics (UK registered charity no. 1111709) (UK)

No information available

The Naandi Foundation (India trust registration number 1745/98) (India)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/07/2017		Yes	No

Editorial Notes

06/07/2017: Publication reference added.