Impact of the Integrated Management of Neonatal and Childhood Illness Strategy on Neonatal and Infant Mortality (IMNCI-India)

This study has been completed.
Sponsor:
Collaborators:
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 (Responsible Party):
NBhandari, Society for Applied Studies
ClinicalTrials.gov Identifier:
NCT00474981
First received: May 16, 2007
Last updated: April 2, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Mortality
Behavioral: IMNCI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Impact of the Integrated Management of Neonatal and Childhood Illness Strategy on Neonatal and Infant Mortality in Haryana, India

Further study details as provided by Society for Applied Studies:

Primary Outcome Measures:
  • 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) [ Time Frame: Over 30 Months ] [ Designated as safety issue: No ]
  • Neonatal mortality (from birth to 28 days of age) in the cohort identified through pregnancy surveillance [ Time Frame: Over 30 Months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Neonatal mortality (from birth to 28 days of age) in the population more likely to benefit from the intervention [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Infant mortality (birth to 365 days) in the communities receiving the intervention. [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Population coverage of key behaviours and interventions [ Time Frame: Over 30 Months ] [ Designated as safety issue: No ]
  • Process of intervention delivery in a randomly selected subsample of activities [ Time Frame: Over 30 Months ] [ Designated as safety issue: No ]

Enrollment: 66600
Study Start Date: June 2006
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
IMNCI
Behavioral: IMNCI
Implementation of IMNCI in the intervention sites
No Intervention: 2
Control

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All births

Exclusion Criteria:

  • None
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00474981

Locations
India
Society for Applied Studies
New Delhi, Delhi, India, 110016
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
Investigators
Principal Investigator: Nita Bhandari, MD, PhD Society for Applied Studies
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NBhandari, Director, Society for Applied Studies
ClinicalTrials.gov Identifier: NCT00474981     History of Changes
Other Study ID Numbers: C6-181-505
Study First Received: May 16, 2007
Last Updated: April 2, 2012
Health Authority: India: Ministry of Health

Keywords provided by Society for Applied Studies:
neonatal mortality
infant mortality
newborn caring practices

ClinicalTrials.gov processed this record on October 22, 2014