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Clinical Trials/NCT02473796
NCT02473796CompletedNot Applicable

Effect of Home Based Child Care on Child Mortality and Malnutrition in a Tribal Population of Melghat, India: Cluster Randomised Control Field Trial

MAHAN Trust2 sites in 1 country7,594 target enrollmentStarted: January 1, 2004Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
7,594
Locations
2
Primary Endpoint
Under-5 mortality rate

Study Overview

Brief Summary

Melghat is poorly developed tribal area in India with very high child mortality & malnutrition prevalence (grossly inadequate medical facilities). Important health problems. Malnutrition , Pneumonia, Tuberculosis, Anaemia, Malaria, Diarrhoea, Premature and L. B. W. babies, Neonatal sepsis, Feeding problem, Birth asphyxia. The investigators developed a Home Based Child Care (HBCC) model to reduce neonatal mortality rate (NMR), infant mortality rate (IMR), under 5 mortality rate (U5MR) and severe malnutrition(SM) in this region.

Melghat.

Need of project :

Melghat is known for highest U5MR in Maharashtra. Overall aims and importance of the research:. The results obtained in this area will be applicable for reducing children mortality and malnutrition in other parts of Melghat and all other tribal areas of India.

Methodology: RCT-Home based child care (HBCC) by trained village health workers .(ARI, Diarrhoea, Malaria clinically & Neonatal care) in 19 villages. Strengthening of existing government ICDS and health system.

Melghat.

Need of project :

Melghat is known for highest U5MR in Maharashtra. Overall aims and importance of the research:. The results obtained in this area will be applicable for reducing children mortality and malnutrition in other parts of Melghat and all other tribal areas of India.

Methodology: RCT- (HBCC) by trained village health workers .(ARI, Diarrhoea, Malaria clinically & Neonatal care) in 19 villages.

Detailed Description

A. Objectives:

  1. To reduce NMR from existing 54 ( year 2004) to 33.6 per 1000 live births in usual residents population of 17000 (from 19 villages in tribal area of Melghat ) over a period of 5 years.
  2. To reduce the IMR from existing 90 (year 2004) to 52.65 per 1000 live births in above area.
  3. To reduce the U5MR from existing 140 (year 2006) to 72.1 per 1000 live births in above area.
  4. To reduce the prevalence of severe malnutrition (under 5 children ) from existing 9.5% (year 2004) to 4.55% in above area.

B. Detailed research plan. I. Study design: Randomised Control Trial. The Melghat area was divided into 5 clusters. 8 villages were randomly selected from each cluster by lottery method. All under 5 children who are ill will be treated by trained VHW.

II. Study period: January 1st, 2004 to 31st April, 2010. III. Study area: 19 villages for intervention and control area with Population of 14888 & 16310 respectively.

IV) Contents of the home based child health Package:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
1 Minute to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All births and deaths in the village or catering hospital were included in the study.
  • All under 5 children in the villages were included in the study.

Exclusion Criteria

  • All births and deaths outside the village were excluded from the study.

Outcomes

Primary Outcomes

Under-5 mortality rate

Time Frame: Four years.

Secondary Outcomes

  • prevalence of severe malnutrition(4 years)

Investigators

Sponsor
MAHAN Trust
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Ashish Rambhau Satav

President MAHAN Trust

MAHAN Trust

Study Sites (2)

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