Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Society for Applied Studies World Health Organization United Nations Children's Fund, New Delhi The Research Council of Norway - Year 3 onwards Society for Essential Health Action and Training, New Delhi - Year 3 onwards |
---|---|
Information provided by: | Society for Applied Studies |
ClinicalTrials.gov Identifier: | NCT00474981 |
This study is a cluster-randomized trial being conducted in the state of Haryana in North India. Eighteen geographical areas served by Primary Health Centres (PHCs) have been randomized to intervention or comparison areas. In the intervention areas, all physicians, health workers and ICDS workers are being trained in the IMNCI. Each of these clusters has an approximate population of 30,000.
The IMNCI intervention includes three main components:
improvement in family and community health care practices which include:
The primary outcome measures of the study are neonatal and infant mortality. The study will also collect information on cause-specific neonatal mortality, ascertained using a standardized previously validated verbal autopsy instrument administered by trained, skilled health workers. All the other outcomes (including initiation of breastfeeding within 1 hour of birth; Exclusive breastfeeding at 4 weeks of age; Proportion of neonates identified to be sick by caregivers who sought care) are secondary outcomes.
The effectiveness of this comprehensive intervention will be measured by comparing the primary and secondary outcome measures in the intervention and comparison clusters, controlling for any baseline differences such as the predefined outcomes and/or socioeconomic status and demography.
The project will serve as a guide to the Government of India of how to best implement the IMNCI strategy and measure its impact.
Condition | Intervention |
---|---|
Mortality |
Behavioral: IMNCI |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Impact of the Integrated Management of Neonatal and Childhood Illness Strategy on Neonatal and Infant Mortality in Haryana, India |
Estimated Enrollment: | 40500 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
IMNCI
|
Behavioral: IMNCI
Implementation of IMNCI in the intervention sites
|
2: No Intervention
Control
|
Ages Eligible for Study: | up to 12 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria: - All births Exclusion Criteria: - None
Contact: Nita Bhandari, MD, PhD | 00 91 11 26014136 | community.research@cih.uib.no |
India, Delhi | |
Society for Applied Studies | Recruiting |
New Delhi, Delhi, India, 110017 | |
Contact: Nita Bhandari, MBBS, PhD 00 91 11 26016599 community.research@cih.uib.no | |
Contact: Sarmila Mazumder, MBBS, MD 00 91 11 26014136 community.research@cih.uib.no |
Principal Investigator: | Nita Bhandari, MD, PhD | Society for Applied Studies |
Responsible Party: | Society for Applied Studies, New Delhi ( Nita Bhandari ) |
Study ID Numbers: | C6-181-505 |
Study First Received: | May 16, 2007 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00474981 History of Changes |
Health Authority: | India: Ministry of Health |
neonatal mortality infant mortality newborn caring practices |