We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Community-Integrated Management of Childhood Illness (IMCI) Programme Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00979797
Recruitment Status : Completed
First Posted : September 18, 2009
Last Update Posted : September 30, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:

The proposed four-year randomized study will attempt to test the hypothesis that community-based child health interventions in conjunction with facility-based IMCI will improve child care practices, nutritional status and child survival. The objectives of this research are:

  1. To measure the effectiveness of the community-based interventions in improving selected child care practices in the community.
  2. To measure the effectiveness of the community-based interventions in improving child nutritional status and in reducing child morbidity and mortality.
  3. To document the process of implementation of community-based interventions at scale to promote selected key family and community practices related to child health.
  4. To undertake cost-effectiveness analysis of the interventions.

Integrated Management of Childhood Illness (IMCI) is a strategy developed by the World Health Organization (WHO) and UNICEF to reduce childhood mortality and morbidity and to contribute to improved growth and development of children under-5 years of age Experience suggests that a purely facility based strategy will not reach the significant portion of the population that does not have access to or choose not to use a health facility. Links between the service providers and families at household levels is essential in order to ensure that families have the knowledge, skills and ability to provide appropriate preventative and curative care to their children. However, globally, actual evidence of effectiveness of community-based IMCI interventions implemented at scale is meager.

C-IMCI in Bangladesh will be implemented by GoB in partnership with NGOs and also through active participation of different community groups, civil societies, and the private sector.

Both GoB and UNICEF/Bangladesh have agreed that an evaluation of the C-IMCI implementation by GoB, as proposed here, would be very opportune and useful in providing the evidence and analysis of lessons that will guide further scale-up in the country.

A cluster-randomized design will be used for this evaluation. Fourteen Upazilas where facility-based IMCI is already in place will be selected, and 7 upazillas will be randomly allocated to C-IMCI intervention and 7 to comparison. Community-based IMCI in the intervention upazillas will be implemented by GoB through the district health system while in the comparison upazillas existing services will continue, including facility-based IMCI.

Condition or disease Intervention/treatment
Childhood Illness Other: Community-based interventions to promote maternal and child health

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: An Assessment of Public Health Effectiveness of Approaches to Promote Key Family & Community Behaviors for Child Survival
Study Start Date : July 2009
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Maternal & Child Health
Community-based interventions to promoto Maternal and Child Survival in collaboration with GoB, Donors and NGOs.
Other: Community-based interventions to promote maternal and child health
Promotion of antenatal and postnatal care and safe delivery Essential Newborn care Community case management, and feeding for children.

Outcome Measures

Primary Outcome Measures :
  1. Under 5 mortality Proportion of sick <5 years old children seeking appropriate care Proportion of 0-5 months old children exclusively breastfed Proportion of <5 years old children <-2 z weight for age [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Care-seeking for childhood illness Antenatal and Postnatal care Deliveries by trained birth attendants Essential newborn care (drying and wrapping, delayed bathing, Breastfeeding) Complementary feeding [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Areas with facility-based IMCI in place

Exclusion Criteria:

  • Children > 5 years
  • Women < 15 and > 49 years
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979797

Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Directorate General for Health Services, Ministry of Health, Bangladesh
Johns Hopkins Bloomberg School of Public Health
World Health Organization
More Information

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT00979797     History of Changes
Other Study ID Numbers: 2007-059
First Posted: September 18, 2009    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 2009

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Community IMCI
Under 5 mortality
Under 5 Nutrition