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

NCT02473796 | Completed DMC

• 1 other identifier: MT-1
• Study Type: interventional
• Target: 7,594
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Tract Infections; Diarrhea; Malaria; Neonatal Sepsis; Birth Asphyxia

Keywords

home based child care

Outcome Measures

Primary Outcomes (1)

• Under-5 mortality rate

  Four years.

Secondary Outcomes (1)

• prevalence of severe malnutrition

  4 years

Study Arms (2)

Home based child care

EXPERIMENTAL

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

control

NO INTERVENTION

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.

Interventions

Home based child care OTHER

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.

Also known as: HBCC

Home based child care

Eligibility Criteria

• Age: 1 Minute - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• MAHAN Trust: lead
• Stitching Geron and Cordaid, The Netherlands.: collaborator
• Caring Friends, Mumbai: collaborator

Study Sites (1)

MAHAN Trust, Melghat (Dharni)

Amravati, Maharashtra, 444 702, India

Location

Related Publications (1)

• Satav AR, Satav KA, Bharadwaj A, Pendharkar J, Dani V, Ughade S, Raje D, Simoes EAF. Effect of home-based childcare on childhood mortality in rural Maharashtra, India: a cluster randomised controlled trial. BMJ Glob Health. 2022 Jul;7(7):e008909. doi: 10.1136/bmjgh-2022-008909.

  PMID: 35851283 DERIVED

MeSH Terms

Conditions

Diarrhea; Malaria; Neonatal Sepsis; Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Sepsis; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes

Study Officials

• Ashish R Satav, MBBS., MD.

  MAHAN

  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: President MAHAN Trust

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: June 17, 2015
• Study Start: January 1, 2004
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2010
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

IN (1)