Impact of the Integrated Management of Neonatal and Childhood Illness Strategy on Neonatal and Infant Mortality

NCT00474981 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66600

Last updated 2012-04-03

No results posted yet for this study

Summary

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.

Conditions

  • Mortality

Interventions

BEHAVIORAL

IMNCI

Implementation of IMNCI in the intervention sites

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER
  • United Nations

    collaborator OTHER
  • The Research Council of Norway

    collaborator OTHER
  • Society for Essential Health Action and Training, New Delhi - Year 3 onwards

    collaborator UNKNOWN
  • Society for Applied Studies

    lead OTHER

Principal Investigators

  • Nita Bhandari, MD, PhD · Society for Applied Studies

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • India

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00474981 on ClinicalTrials.gov