NCT00979797.

Study name	Community‐Integrated Management of Childhood Illness (IMCI) programme evaluation Official title: an assessment of public health effectiveness of approaches to promote key family and community behaviours for child survival
Methods	Design: cluster‐randomized controlled trial Unit of randomization: Upazilas (subdistricts)
Participants	Inclusion criteria: children aged < 5 years and women aged 15–49 years in areas with facility‐based IMCI in place Exclusion criteria: children aged > 5 years; women aged < 15 and > 49 years
Interventions	Intervention Community‐based IMCI in the intervention upazillas will be implemented through the district health system while in the comparison upazillas existing services will continue, including facility‐based IMCI Comparison Usual health facility services, including facility‐based IMCI
Outcomes	Primary outcomes: under‐5 mortality; coverage of appropriate careseeking for childhood illness; coverage of exclusive breastfeeding; nutritional status (weight‐for‐age) Other outcomes measured: antenatal and postnatal care; deliveries by trained birth attendants; essential newborn care (drying and wrapping, delayed bathing, breastfeeding; complementary feeding; quality of care provided by health workers
Starting date	July 2009
Contact information	International Centre for Diarrhoeal Disease Research, Bangladesh
Notes	Objective: the proposed 4‐year randomized study will attempt to test the hypothesis that community‐based child health interventions in conjunction with facility‐based IMCI will improve childcare practices, nutritional status and child survival. The objectives of this research are: to measure the effectiveness of the community‐based interventions in improving selected childcare practices in the community; to measure the effectiveness of the community‐based interventions in improving child nutritional status and in reducing child morbidity and mortality; to document the process of implementation of community‐based interventions at scale to promote selected key family and community practices related to child health; to undertake cost‐effectiveness analysis of the interventions. Location: 14 Upazilas (subdistricts) in Bangladesh. Funding source: the record on ClinicalTrials.gov indicates the following sponsors and collaborators but it is not clear whether these are the same as the funding source: 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; UNICEF. Notes: according to the record on ClinicaTrials.gov (clinicaltrials.gov/ct2/show/record/NCT00979797), the study started in July 2009 and final data collection for primary outcomes occurred in December 2013. The record indicates, "Results information has been submitted to ClinicalTrials.gov by the sponsor or investigator, but is not yet publicly available (or "posted") on ClinicalTrials.gov. The submitted information may not be available if it is pending Quality Control (QC) Review by the National Library of Medicine (NLM) or if issues identified during QC review are being addressed or corrected by the sponsor or investigator. NLM's limited QC review assesses for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information." The results were submitted to ClinicalTrials.gov on 2 June 2018 and results returned after quality control review on 28 December 2018.