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

NCT00474981 | Completed

• 1 other identifier: C6-181-505
• Study Type: interventional
• Target: 66,600
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

neonatal mortality; infant mortality; newborn caring practices

Outcome Measures

Primary Outcomes (5)

• 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

• Neonatal mortality (from birth to 28 days of age) in the cohort identified through pregnancy surveillance

  Over 30 Months

• 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

• Neonatal mortality (from birth to 28 days of age) in the population more likely to benefit from the intervention

  30 months

• Infant mortality (birth to 365 days) in the communities receiving the intervention.

  30 months

Secondary Outcomes (2)

• Population coverage of key behaviours and interventions

  Over 30 Months

• Process of intervention delivery in a randomly selected subsample of activities

  Over 30 Months

Study Arms (2)

1

EXPERIMENTAL

IMNCI

Behavioral: IMNCI

2

NO INTERVENTION

Control

Interventions

IMNCI BEHAVIORAL

Implementation of IMNCI in the intervention sites

1

Eligibility Criteria

• Age: 1 Minute - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All births

You may not qualify if:

• None

Sponsors & Collaborators

• Society for Applied Studies: lead
• World Health Organization: collaborator
• United Nations: collaborator
• The Research Council of Norway: collaborator
• Society for Essential Health Action and Training, New Delhi - Year 3 onwards: collaborator

Study Sites (1)

Society for Applied Studies

New Delhi, National Capital Territory of Delhi, 110016, India

Location

Related Publications (4)

• 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 trial. BMJ. 2012 Mar 21;344:e1634. doi: 10.1136/bmj.e1634.

  PMID: 22438367 RESULT

• Chowdhury R, Taneja S, Mazumder S, Bhandari N, Strand TA. Gender differences in infant survival: a secondary data analysis in rural North India. BMJ Open. 2017 Aug 11;7(8):e014179. doi: 10.1136/bmjopen-2016-014179.

  PMID: 28801386 DERIVED

• Taneja S, Bahl S, Mazumder S, Martines J, Bhandari N, Bhan MK. Impact on inequities in health indicators: Effect of implementing the integrated management of neonatal and childhood illness programme in Haryana, India. J Glob Health. 2015 Jun;5(1):010401. doi: 10.7189/jogh.05.010401.

  PMID: 25674350 DERIVED

• Mazumder S, Taneja S, Bahl R, Mohan P, Strand TA, Sommerfelt H, Kirkwood BR, Goyal N, Van Den Hombergh H, Martines J, Bhandari N; Integrated Management of Neonatal and Childhood Illness Evaluation Study Group. Effect of implementation of integrated management of neonatal and childhood illness programme on treatment seeking practices for morbidities in infants: cluster randomised trial. BMJ. 2014 Aug 29;349:g4988. doi: 10.1136/bmj.g4988.

  PMID: 25172514 DERIVED

MeSH Terms

Conditions

Infant Death

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nita Bhandari, MD, PhD

  Society for Applied Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Study Start: June 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 3, 2012

Record last verified: 2012-04

Locations

IN (1)