NCT00979797

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. 1.To measure the effectiveness of the community-based interventions in improving selected child care practices in the community.
  2. 2.To measure the effectiveness of the community-based interventions in improving child nutritional status and in reducing child morbidity and mortality.
  3. 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. 4.To undertake cost-effectiveness analysis of the interventions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 30, 2014

Status Verified

September 1, 2009

Enrollment Period

4.4 years

First QC Date

September 17, 2009

Last Update Submit

September 28, 2014

Conditions

Childhood Illness

Keywords

Community IMCIC-IMCICHWChildrenEvaluationBehaviourCounsellingUnder 5 mortalityUnder 5 Nutrition

Outcome Measures

Primary Outcomes (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

    24 months

Secondary Outcomes (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

    24 months

Study Arms (1)

Maternal & Child Health

EXPERIMENTAL

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

Interventions

Community-based interventions to promote maternal and child healthOTHER

Promotion of antenatal and postnatal care and safe delivery Essential Newborn care Community case management, and feeding for children.

Maternal & Child Health

Eligibility Criteria

AgeUp to 49 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Areas with facility-based IMCI in place

You may not qualify if:

  • Children \> 5 years
  • Women \< 15 and \> 49 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICDDR,B

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Conditions

Behavior

Interventions

Child Health

Intervention Hierarchy (Ancestors)

HealthPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2009

First Posted

September 18, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 30, 2014

Record last verified: 2009-09

Locations

BA(1)