Condition category
Neonatal Diseases
Date applied
07/02/2007
Date assigned
20/03/2007
Last edited
09/10/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

In progress at the Institutional Review Board of the L.V. Prasad Eye Institute, Hyderabad, India (Protocol number LEC07002)

Study design

The trial is a unblinded cluster-randomised controlled trial involving 464 villages, with the village as the unit of randomisation and neonatal mortality as the primary outcome

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Neonatal mortality

Intervention

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

http://www.effint.org/

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

Publication citations

Additional files

Editorial Notes