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

Society for Applied Studies

Status: Completed

Conditions: Low-Birth-Weight

Treatments: Behavioral: Kangaroo Mother Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02653534

2015/1486/REK vest

Details and patient eligibility

About

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.

Enrollment: 8,402 patients

Sex: All

Ages: Under 3 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8,402 participants in 2 patient groups

Intervention Kangaroo Mother Care

Experimental group

Description:

Promotion of, and support for lactation management and skin to skin care as soon as possible after birth by study ANM supported by study ASHA in addition to routine visits by government health workers

Treatment:

Behavioral: Kangaroo Mother Care

Control

No Intervention group

Description:

Routine visits by government health workers