Contact information
Type
Scientific
Primary contact
Dr Robert Scherpbier
ORCID ID
Contact details
Department of Child and Adolescent Health and Development
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 2693
scherpbierr@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
MCE-Bangladesh
Study hypothesis
Child health interventions delivered as Integrated Management of Childhood Illness (IMCI) will achieve greater improvements in health status and be more cost-effective than when reliance is placed on similar, but vertically organised health programmes.
Ethics approval
The Ethical Review Committee (ERC) of ICDDR,B is legally established body for the review research protocols involving humans under a specific Bangladesh law. The ERC has a Federal Wide Assurance (FWA) with the US Government (FWA#00001468). Ethics approval was gained on the 28th August 2006 (the reference number for this protocol from ERC of ICDDR, B is 1999-009).
Study design
Randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Diseases and conditions included in IMCI: nutritional status and major causes of childhood death (including Acute Respiratory Illness [ARI], diarrhoea, and newborn conditions) and child health in general
Intervention
1. Facility-based Integrated Management of Childhood Illness (IMCI) interventions: started from March 2002 and is still ongoing
2. Community-based Integrated Management of Childhood Illness (IMCI) interventions: consists of different subcomponents which were gradually phased in from June 2003 and are still ongoing
3. Health systems support: started from March 2002 and is still ongoing
Principal Investigator:
Shams El Arifeen
ICDDRB
GPO Box 128
Dhaka 1000
Bangladesh
Tel: +880 (0)2 881 0115
Email: shams@icddrb.org
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Under-five mortality: baseline measured in 2000, midterm in intervention are in 2005 and end-of-project in 2007
2. Under-five nutritional status: baseline measured in 2000 and end-of-project in 2007
Secondary outcome measures
1. Quality, coverage and utilisation of IMCI services: baseline measured in 2000, and in 2003 and 2005
2. Client satisfaction: measured continuously from June 2003
3. Family and community practices related to IMCI: measured continously from 2002
4. Costs and cost-effectiveness of IMCI implementation: baseline measured in 2000 and end-of-project in 2007
Overall trial start date
01/10/1999
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
All under-five children and their caretakers who are residents of the study area.
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
40000
Participant exclusion criteria
Do not meet the criteria above.
Recruitment start date
01/10/1999
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Bangladesh
Trial participating centre
Department of Child and Adolescent Health and Development
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Sponsor details
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Bill and Melinda Gates Foundation (USA)
Alternative name(s)
Bill & Melinda Gates Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United States of America
Funder name
United States Agency for International Development (USA)
Alternative name(s)
USAID
Funding Body Type
government organisation
Funding Body Subtype
federal/national government
Location
United States of America
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