Impact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants

Not Applicable

Completed

• Conditions: Low-Birth-Weight

• Registration Number: NCT02653534
• Lead Sponsor: Society for Applied Studies

Brief Summary

This study is being conducted to assess the impact of promoting community initiated Kangaroo Mother Care (ciKMC) for low birth weight babies on post enrolment neonatal mortality and mortality post enrolment upto 6 months of age. This large individually randomized controlled trial will enroll 10500 low birth weight babies. The secondary objectives are examining the impact of the intervention on exclusive breast feeding and growth at 1 and 3 months, infections and hospitalizations in the neonatal period and from 1 to 5 months of age, recognition of illnesses and early care seeking from appropriate sources, motor and mental development in a subsample.

Newborns weighing \>=1500 to \<=2250gm are being enrolled into the study within 3 days of birth. Eligible babies are randomized to intervention or control arms. Mothers in the intervention arm are supported for KMC and breastfeeding by study ANM (Auxiliary Nurse Midwife) and study ASHA (Accredited Social Health Activist) like workers . Routine home visits are conducted in both intervention and control arms by government workers according to the existing government program.

Survival will be ascertained in all enrolled infants through contacts at 1, 3 and 6 months.

The data safety and monitoring committee (DSMC) conducted two interim analyses, first in September 2017 when about half of the infants had been enrolled, and second in June 2018, when almost three quarters of the enrolled babies had been followed till 28 days of age. Following the second interim analysis, the DSMC concluded that a sufficient number of infants would be enrolled by the end to September 2018 to clearly answer the study question concerning the impact of ciKMC on both neonatal and early infant mortality. The DSMC recommended that data collection be completed by the end of October 2018.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Status Verified: 2015-12
• Study First Submitted: 2015-12-26
• Study First Submitted QC: 2016-01-09
• Study First Posted: 2016-01-12
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2018-12-06
• Last Update Posted: 2018-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8402

Inclusion Criteria

Low birth weight babies (≥1500 to ≤2250 g) screened within 3 days and their mothers.

• Born at home
• Singleton or twins or triplets
• Infants born in hospital, discharged and KMC not initiated in the hospital

Exclusion Criteria

• Infant unable to feed
• Infant has breathing problem
• Infant is less active than normal
• Gross congenital malformations
• Mother does not intend to stay in the study area for the next 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Early infant mortality from post enrolment to 6 months of age	From post enrolment to 6 months
Neonatal mortality from post enrolment to 28 days	From post enrolment to 28 days

Secondary Outcome Measures

Name	Time	Method
Weight gain	1, 3 and 6 months
Incidence of infection and hospitalization	1 month and 1 to 5 months
Early appropriate care seeking practices at 3 months	Assessed at 3 months, data from 1 month upto 3 months	Early appropriate care-seeking ascertained from caregivers by using questionnaire
Early appropriate care seeking practices at 6 months	Assessed at 6 months, data from 3 months upto 6 months	Early appropriate care-seeking practices ascertained by using questionnaire
Length gain	1, 3 and 6 months
Early appropriate care seeking practices at 1 month	1 month period	Early appropriate care seeking ascertained from caregivers by using questionnaire
Early recognition of illness at 1 month	1 month period	Recognition of illness will be ascertained from caregivers by using questionnaire
Early recognition of illness at 3 months	Assessed at 3 months, data from 1 month upto 3 months	Recognition of illness ascertained from caregivers by using questionnaire
Early recognition of illness at 6 months	Assessed at 6 months, data from 3 months upto 6 months	Recognition of illness ascertained from caregivers by using questionnaire
Assessment of cognitive function by Bayley scale in a subsample	Assessment of cognitive function by Bayley scale at 12 months
Head circumference	1, 3 and 6 months
Proportion exclusively breastfed at 1 and 3 months	1 month, 3 months

Trial Locations

Locations (1)

CHRD, Society for Applied Studies; 🇮🇳 Palwal, Haryana, India