| CTRI Number |
CTRI/2009/091/000715 [Registered on: 09/12/2009] |
| Last Modified On: |
12/08/2014 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Other (Specify) [Health Service Research] |
| Study Design |
Cluster Randomized Trial |
Public Title of Study
Modification(s)
|
Evaluation of the impact of the integrated management of neonatal and childhood illness strategy on neonatal and infant mortality in Haryana, India |
Scientific Title of Study
Modification(s)
|
Evaluation of the impact of the integrated management of neonatal and childhood illness strategy on neonatal and infant mortality in Haryana, India |
| Trial Acronym |
IMNCI-India |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT00474981 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Nita Bhandari |
| Designation |
Director |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
45, Kalu Sarai
New Delhi
DELHI
110016
India |
| Phone |
01146043751 |
| Fax |
01146043756 |
| Email |
CHRD@sas.org.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Nita Bhandari |
| Designation |
Director |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
45, Kalu Sarai
New Delhi
DELHI
110016
India |
| Phone |
01146043751 |
| Fax |
01146043756 |
| Email |
CHRD@sas.org.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Nita Bhandari |
| Designation |
Director |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
45, Kalu Sarai
New Delhi
DELHI
110016
India |
| Phone |
01146043751 |
| Fax |
01146043756 |
| Email |
CHRD@sas.org.in |
|
Source of Monetary or Material Support
Modification(s)
|
| World Health Organization, Geneva; UNICEF, New Delhi; Research Council of Norway, Norway |
|
Primary Sponsor
Modification(s)
|
| Name |
Nita Bhandari |
| Address |
Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi-11016 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nita Bhandari |
Centre for Health Research and Development, Society for Applied Studies |
45, Kalu Sarai,-110016
New Delhi
DELHI |
01146043751
01146043756
CHRD@sas.org.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Society for Applied Studies Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Neonatal and infant mortality |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implementation of IMNCI in the intervention sites |
IMNCI |
| Comparator Agent |
Routine Health Care |
Government |
|
Inclusion Criteria
Modification(s)
|
| Age From |
0.00 Day(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
All births
|
|
| ExclusionCriteria |
|
Method of Generating Random Sequence
Modification(s)
|
Stratified randomization |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
POST DAY 1 NEONATAL MORTALITY and NEONATAL MORTALITY in the communities receiving the intervention (cohort of infants born to women identified through pregnancy surveillance)
POST DAY 1 NEONATAL MORTALITY and NEONATAL MORTALITY in the population of newborns who are more likely to have greater impact from the intervention i.e. those born at home and available in the study area within 7 days of birth
INFANT MORTALITY (birth to 365 days) in the communities receiving the intervention
|
30 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Population coverage of key behaviours and interventions |
30 months |
| Process of intervention delivery in a randomly selected subsample of activities |
30 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="66600"
Sample Size from India="66600"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
01/01/2008 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="4"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Bhandari N, Mazumder S, Taneja S, Sommerfelt H, Strand TA on behalf of the IMNCI Evaluation Study Group. Effect of implementation of Integrated Management of Neonatal and Childhood Illness (IMNCI) programme on neonatal and infant mortality: cluster randomised controlled trial. BMJ 2012;344:e1634 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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 the case management skills of health staff
improvement in the overall health system to support its performance, and
improvement in family and community health care practices which include:
prevention and management of hypothermia
early initiation of breastfeeding and exclusive breastfeeding
community-based care of low birth weight infants
improved care-seeking for neonatal infections
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.
|