Mortality Clinical Trial
— IMNCI-IndiaOfficial title:
Impact of the Integrated Management of Neonatal and Childhood Illness Strategy on Neonatal and Infant Mortality in Haryana, India
Verified date | April 2012 |
Source | Society for Applied Studies |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Ministry of Health |
Study type | Interventional |
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:
1. improvement in the case management skills of health staff
2. improvement in the overall health system to support its performance, and
3. 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.
Status | Completed |
Enrollment | 66600 |
Est. completion date | April 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 12 Months |
Eligibility |
Inclusion Criteria: - All births Exclusion Criteria: |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
India | Society for Applied Studies | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Society for Applied Studies | Society for Essential Health Action and Training, New Delhi - Year 3 onwards, The Research Council of Norway, United Nations, World Health Organization |
India,
Bhandari N, Mazumder S, Taneja S, Sommerfelt H, Strand TA; 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post day 1 Neonatal mortality (birth to 28 days of age) in the communities receiving the intervention(cohort of infants born to women identified through pregnancy surveillance) | Over 30 Months | No | |
Primary | Neonatal mortality (from birth to 28 days of age) in the cohort identified through pregnancy surveillance | Over 30 Months | No | |
Primary | Post day 1 neonatal mortality (1 to 28 days of age) 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 | 30 months | No | |
Primary | Neonatal mortality (from birth to 28 days of age) in the population more likely to benefit from the intervention | 30 months | No | |
Primary | Infant mortality (birth to 365 days) in the communities receiving the intervention. | 30 months | No | |
Secondary | Population coverage of key behaviours and interventions | Over 30 Months | No | |
Secondary | Process of intervention delivery in a randomly selected subsample of activities | Over 30 Months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04092465 -
Outcomes of Surgical Resection After Induction Treatment in Non-Small Cell Lung Cancer (SRaIT)
|
||
Completed |
NCT03296423 -
Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly
|
Phase 4 | |
Not yet recruiting |
NCT04900610 -
The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis
|
N/A | |
Completed |
NCT04149873 -
Effectness of Treatment With Mechanical Insufflation-Exsufflation
|
N/A | |
Completed |
NCT05905042 -
Follow-up of Recovery Condition in Survivors of Acute Respiratory Distress Syndrome
|
||
Completed |
NCT00527774 -
Effect of HCV Infection on Insulin Resistance and Malnutrition-inflammation Complex Syndrome in Regular Hemodialysis Patients
|
N/A | |
Completed |
NCT00518856 -
Lufwanyama Neonatal Survival Project
|
N/A | |
Completed |
NCT06408636 -
Prognostic Role of LA Strain in Acute Myocardial Infarction
|
||
Completed |
NCT06051526 -
The African Critical Illness Outcomes Study
|
||
Recruiting |
NCT05055089 -
Short- and Medium-term Results of New Generation Aortic
|
||
Active, not recruiting |
NCT04132492 -
AGNES - Aging Nephropathy Study, a Prospective Observational Cohort of Chronic Kidney Disease in Elderly Patients
|
||
Completed |
NCT03885206 -
Effectiveness and Clinical Outcomes of Municipal Acute Wards Versus a General Hospital
|
N/A | |
Completed |
NCT05573659 -
Capillary Refill Time Calculated With a Video-assisted Method Has a Better Reproducibility Than Visual Method in Critically Ill Patients
|
N/A | |
Withdrawn |
NCT03245658 -
The Effect of Cannabis in Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT04094428 -
Burden, Mortality and Supply Costs in Intensive Care Unit Patients
|
||
Completed |
NCT01631799 -
Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia
|
N/A | |
Completed |
NCT00244673 -
Randomized Study of Not Giving Diphteria-tetanus-pertussis Vaccination With or After Measles Vaccination
|
Phase 4 | |
Completed |
NCT03378843 -
Spermidine Intake and All-cause Mortality
|
N/A | |
Recruiting |
NCT04424511 -
Effects of Mass Drug Administration of Azithromycin on Mortality and Other Outcomes Among 1-11 Month Old Infants in Mali
|
Phase 3 |