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Home Based Child Care to Reduce Mortality and Malnutrition in Tribal Children of Melghat, India: CRCT (HBCC)

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ClinicalTrials.gov Identifier: NCT02473796
Recruitment Status : Completed
First Posted : June 17, 2015
Last Update Posted : March 16, 2016
Sponsor:
Collaborators:
Stitching Geron and Cordaid, The Netherlands.
Caring Friends, Mumbai
Information provided by (Responsible Party):
Dr. Ashish Rambhau Satav, MAHAN Trust

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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Tract Infections Diarrhea Malaria Neonatal Sepsis Birth Asphyxia Other: Home based child care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7594 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effect of Home Based Child Care on Child Mortality and Malnutrition in a Tribal Population of Melghat, India: Cluster Randomised Control Field Trial
Study Start Date : January 2004
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Home based child care
The home based child care included treatment of various various childhood illnessed by locally avialable trained village health workers, improving hygiene and nutrition among children and women throgh health education. This care was in adiition to the local health care provided by the Government's primary health care services.
Other: Home based child care
HBNC included treatment of neonatal sepsis with Gentamicin once daily (5 mg for 10 days for preterm babies with birth weight <2000g; 7 mg for birth weight 2000-2500 gm or as per gentamicin chart for 7 days for normal term & weight ) by intramuscular injection. Acute respiratory infection was treated with co-trimoxazole syrup BID (2.5 ml for age 1-2 months, 5 ml for age 2 months - 1 year, 7.5 ml for age 1 - 5 years). Diarrheal illness was treated with ORS, furoxone (5 ml 8 hourly for 3 days) and metronidazole syrup (5 ml 8 hourly for 7 days). Malaria was treated with Syrup chloroquine (for 1 month to 1 year- 5 ml first dose , 2.5 ml after 6 hours, 2.5 ml after 12 hours , 2.5 ml after 12 hours). Syrup paracetamol was given 2.5 to 5 ml 8 hourly depending upon the body weight.
Other Name: HBCC

No Intervention: control
The control arm included population where the home based neonatal care was not implimented. The health services were provided by the Government run primary health care services. Vital statistics data was collected by VHWs.



Primary Outcome Measures :
  1. Under-5 mortality rate [ Time Frame: Four years. ]

Secondary Outcome Measures :
  1. prevalence of severe malnutrition [ Time Frame: 4 years ]


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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473796


Locations
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India
MAHAN Trust, Melghat (Dharni)
Amaravati, Maharashtra, India, 444 702
Sponsors and Collaborators
MAHAN Trust
Stitching Geron and Cordaid, The Netherlands.
Caring Friends, Mumbai
Investigators
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Principal Investigator: Ashish R Satav, MBBS., MD. MAHAN
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Responsible Party: Dr. Ashish Rambhau Satav, President MAHAN Trust, MAHAN Trust
ClinicalTrials.gov Identifier: NCT02473796    
Other Study ID Numbers: MT-1
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Keywords provided by Dr. Ashish Rambhau Satav, MAHAN Trust:
home based child care
Additional relevant MeSH terms:
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Respiratory Tract Infections
Neonatal Sepsis
Asphyxia Neonatorum
Malnutrition
Diarrhea
Asphyxia
Signs and Symptoms, Digestive
Nutrition Disorders
Infection
Respiratory Tract Diseases
Sepsis
Infant, Newborn, Diseases
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Death
Wounds and Injuries