An evaluation of the health and economic impact of integrated management of childhood illness in Matlab, Bangladesh: a randomised experimental study

ISRCTN	ISRCTN52793850
DOI	https://doi.org/10.1186/ISRCTN52793850
Secondary identifying numbers	N/A

Submission date: 17/05/2007
Registration date: 22/06/2007
Last edited: 22/05/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Robert Scherpbier
Scientific

Department of Child and Adolescent Health and Development
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Phone	+41 (0)22 791 2693
Email	scherpbierr@who.int

Study information

Study design	Randomised trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Scientific title	An evaluation of the health and economic impact of integrated management of childhood illness in Matlab, Bangladesh: a randomised experimental study
Study acronym	MCE-Bangladesh
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/10/1999
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	5 Years
Sex	Not Specified
Target number of participants	40000
Total final enrolment	350000
Key inclusion criteria	All under-five children and their caretakers who are residents of the study area.
Key exclusion criteria	Do not meet the criteria above.
Date of first enrolment	01/10/1999
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Bangladesh
Switzerland

Study participating centre

Department of Child and Adolescent Health and Development

Geneva-27
CH-1211
Switzerland

Sponsor information

The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Research organisation

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Website	http://www.who.int/
"ROR"	https://ror.org/01f80g185

Funders

Funder type

Government

Bill and Melinda Gates Foundation (USA)
Government organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
Location: United States of America

United States Agency for International Development (USA)
Government organisation / National government

Alternative name(s): U.S. Agency for International Development, Agency for International Development, USAID
Location: United States of America

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	01/08/2009	22/05/2019	Yes	No

Editorial Notes

22/05/2019: Publication reference and total final enrolment added.