Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/05/2007
Date assigned
22/06/2007
Last edited
11/09/2007
Prospective/Retrospective
Retrospectively 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 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

http://www.who.int/

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

Publication citations

Additional files

Editorial Notes