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History of Changes for Study: NCT00474981
Evaluation of the Impact of the Integrated Management of Neonatal and Childhood Illness Strategy on Neonatal and Infant Mortality (IMNCI-India)
Latest version (submitted April 2, 2012) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 16, 2007 None (earliest Version on record)
2 May 19, 2007 Conditions and Study Status
3 November 2, 2007 Arms and Interventions, Study Design, Study Description and Study Status
4 July 1, 2008 Study Status, Sponsor/Collaborators, Study Identification, Eligibility and Study Description
5 February 19, 2009 Study Status
6 September 7, 2009 Outcome Measures, Study Status and Study Description
7 February 5, 2010 Study Description and Study Status
8 July 28, 2011 Recruitment Status, Study Status, Contacts/Locations, Study Design and Study Description
9 April 2, 2012 Sponsor/Collaborators, Study Status, References and Study Description
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Study NCT00474981
Submitted Date:  May 16, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: C6-181-505
Brief Title: Evaluation of the Impact of the Integrated Management of Neonatal and Childhood Illness Strategy on Neonatal and Infant Mortality (IMNCI-India)
Official Title: Evaluation of the Impact of the Integrated Management of Neonatal and Childhood Illness Strategy on Neonatal and Infant Mortality in Haryana, India
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2007
Overall Status: Recruiting
Study Start: June 2006
Primary Completion:
Study Completion: September 2010 [Anticipated]
First Submitted: May 16, 2007
First Submitted that
Met QC Criteria:
May 16, 2007
First Posted: May 17, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 16, 2007
Last Update Posted: May 17, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Society for Applied Studies
Responsible Party:
Collaborators: World Health Organization
United Nations
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:

  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 measure 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.

Detailed Description:

OBJECTIVES

The primary objective of this study is to determine the effectiveness of delivering community and facility based newborn interventions as part of the IMNCI strategy, in reducing neonatal (birth to 28 days) and infant mortality.

The study will have the following secondary objectives:

To determine the effect of delivering community and facility based newborn interventions as part of the IMNCI strategy on newborn care practices in households.

To determine the effect of delivering community and facility based newborn interventions as part of the IMNCI strategy on health care provider practices.

SAMPLE SIZE ESTIMATES

Neonatal mortality rates were estimated using data from births and deaths obtained in a baseline survey. The neonatal mortality rate in the 18 clusters ranged from 19.6 to 51 per thousand live births with an average of ~30/1000 live births. The sample sizes were calculated according to the method described for cluster randomized trials elsewhere (1). All births (~ 30,000) in the 18 clusters will be registered over a 30 months period. This will enable us to detect a 25% lower mortality rate between the intervention and control sites with 80% power. In order to detect a difference in careseeking behaviour of 10% with a 90% power, we need to undertake interviews of 100 randomly selected women per cluster. For the outcomes "Maternal knowledge about when to seek care" and "Breastfeeding initiation within one hour", the sample size requirements are lower (i.e. fewer interviews per cluster are needed to achieve 90% power).

THE INTERVENTION

The intervention was designed following the guidelines developed by the Government of India in collaboration with the WHO and UNICEF (2). The intervention includes three main components:

  1. Improving the case management skills of health staff.

    Physicians with a medical degree (MBBS or MBBS with a postgraduate degree), supervisors and other health workers in the intervention sites working in the public sector along with AWWs are being trained in IMNCI through an 8 days intensive course (2). A set of orientation material is being designed for TBAs, registered medical practitioners and medically qualified physicians working in the private sector.

  2. Strengthening of health systems.

    As part of its collaboration with the project, efforts will be undertaken by the District Medical Officer's team to implement the following health system improvements:

    Availability of drugs and supplies needed for IMNCI: A list of essential IMNCI drugs and supplies will be displayed in the health facility and used as a checklist during Supervisory Visits.

    Improving referral pathways and services: The health facilities will keep records of cases attended, cases referred and problems reviewed in supervisory visits and review meetings between the person from the local health team that is incharge of the program and different categories of health workers.

    Supervisory visits: Both scheduled and unscheduled visits will be conducted by supervisors trained in IMNCI. Supervisors will review the availability of facility support and drugs to implement IMNCI, as well as health workers' performance, and provide feedback and help in problem-solving.

  3. Improvement in family and community practices.

The aim of this component of the IMNCI strategy is to initiate, reinforce and sustain the key family practices for child survival, growth and development. Practices that are of particular importance for newborn health (early initiation of breastfeeding and avoidance of pre-lacteal feeds; keeping the baby warm, avoiding early bathing, cord hygiene, care seeking for danger signs and special attention for LBW newborns) will be promoted in addition to the standard IMCI key practices (3).

OUTCOME ASCERTAINMENT

Outcomes will be measured through door to door surveys conducted in each PHC every 3 months by field workers. The first survey will be conducted 3 months after training is completed and other components of the intervention are in place.

At each survey, the following outcomes will be ascertained since the previous survey.

  • Births
  • Deaths of infants
  • Newborn caring practices in infants aged <28 days
  • Verbal autopsies in infant deaths

PROCESS EVALUATION ACTIVITIES

These will be conducted by a separate team both in the intervention and control clusters and will focus on activities that ascertain how well the intervention is being implemented. The evaluation will be conducted in a subsample of the various activities in each of the 18 clusters and will include the following:

  • Observations of health care providers during consultations with caregivers of infants aged <28 days and infants between 1 to 11 months of age (in both intervention and control communities)
  • Exit interviews with mothers who have recently visited a health care provider for treatment of illness in an infant aged <28 days and infants between 1 to 11 months of age (in both intervention and control communities).
  • Interviews with caregivers/mothers with a young infant who were visited at home recently by a health worker (in intervention communities only) The healthcare providers for whom the observations/exit interviews are to be conducted will be randomly selected. Repeat visits on a later date will have to be made by the process evaluation team member if a health worker is not available on a day which was scheduled for her/his visit.

DATA MANAGEMENT

Forms filled in the field will be self-checked for missing information, data ranges and consistency by the person filling the form (and the same day by supervisors in the field office). Double data entry will be conducted with range and consistency checks incorporated. This will be followed by validation.

ANALYSIS

Socioeconomic, environmental and demographic characteristics of the intervention and control clusters will be examined for group comparability. Effectiveness will be calculated by comparing the primary and secondary outcome measures in the intervention and control clusters, controlling for any socioeconomic, environmental or demographic differences at baseline and adjusting for the design effect induced by the cluster design. Data analysis will be carried out using Stata.

REFERENCES

  1. Smith PG, Morrow RH. Field trials of health interventions in developing countries: a toolbox. London: Macmillan Education, 1996
  2. Government of India. Operational Guidelines for Implementation of Integrated Management of Neonatal and Childhood Illness (IMNCI). Ministry of Health Family Welfare: New Delhi, 2006.
  3. World Health Organization. Integrated Management of Childhood Illness. Geneva: World Health Organization, 1997 (WHO/CHD/97.3E).
Open or close this module Conditions
Conditions: Integrated Management of Neonatal and Childhood Illness
Keywords: neonatal mortality, infant mortality, newborn caring practices
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 30000 [Anticipated]
Open or close this module Arms and Interventions
Intervention Details:
Behavioral: IMNCI
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Neonatal mortality (birth to 28 days)
[ Time Frame: Over 30 Months ]

2. Infant mortality (birth to 365 days)
[ Time Frame: Over 30 Months ]

Secondary Outcome Measures:
1. Population coverage of key behaviours and interventions
[ Time Frame: Over 30 Months ]

2. Process of intervention delivery in a randomly selected subsample of activities
[ Time Frame: Over 30 Months ]

Open or close this module Eligibility
Minimum Age:
Maximum Age: 12 Months
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • All infants <=12 months residing in the area including new births over a 30 month period

Exclusion Criteria:

  • Visitors to the area
Open or close this module Contacts/Locations
Central Contact Person: Nita Bhandari, MD, PhD
Telephone: 00 91 11 26014136
Email: community.research@cih.uib.no
Study Officials: Nita Bhandari, MD, PhD
Principal Investigator
Society for Applied Studies
Locations: India, Delhi
Society for Applied Studies
[Recruiting]
New Delhi, Delhi, India, 110017
Contact:Contact: Nita Bhandari, MBBS, PhD 00 91 11 26016599 community.research@cih.uib.no
Contact:Contact: Sarmila Mazumder, MBBS, MD 00 91 11 26014136 community.research@cih.uib.no
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Plan to Share IPD:
Open or close this module References
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Available IPD/Information:

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