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

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.

Study Overview

• Status: Completed
• Conditions: Low-Birth-Weight
• Intervention / Treatment: Behavioral: Kangaroo Mother Care

• Study Type: Interventional
• Enrollment (Actual): 8402
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Palwal, Haryana, India, 121102
      • CHRD, Society for Applied Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 days (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Kangaroo Mother Care; 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	Behavioral: Kangaroo Mother Care; 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
No Intervention: Control; Routine visits by government health workers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neonatal mortality from post enrolment to 28 days	From post enrolment to 28 days
Early infant mortality from post enrolment to 6 months of age	From post enrolment to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Society for Applied Studies
• Collaborators: Centre For International Health
• Investigators: Principal Investigator: Dr. Sarmila Mazumder, MBBS, PhD, Society for Applied Studies

Publications and helpful links

General Publications

• Mazumder S, Taneja S, Dube B, Bhatia K, Ghosh R, Shekhar M, Sinha B, Bahl R, Martines J, Bhan MK, Sommerfelt H, Bhandari N. Effect of community-initiated kangaroo mother care on survival of infants with low birthweight: a randomised controlled trial. Lancet. 2019 Nov 9;394(10210):1724-1736. doi: 10.1016/S0140-6736(19)32223-8. Epub 2019 Oct 4.
• Choudhary TS, Kumar M, Sinha B, Shaikh S, Mazumder S, Taneja S, Bhandari N. Anthropometric Indicators as Predictors of Mortality in Early Life Among Low Birthweight Indian Infants. Front Nutr. 2022 Jul 12;9:884207. doi: 10.3389/fnut.2022.884207. eCollection 2022.
• Sinha B, Choudhary TS, Nitika N, Kumar M, Mazumder S, Taneja S, Bhandari N. Linear Growth Trajectories, Catch-up Growth, and Its Predictors Among North Indian Small-for-Gestational Age Low Birthweight Infants: A Secondary Data Analysis. Front Nutr. 2022 May 24;9:827589. doi: 10.3389/fnut.2022.827589. eCollection 2022.
• Choudhary TS, Mazumder S, Haaland OA, Taneja S, Bahl R, Martines J, Bhan MK, Johansson KA, Sommerfelt H, Bhandari N, Norheim OF. Health equity impact of community-initiated kangaroo mother care: a randomized controlled trial. Int J Equity Health. 2021 Dec 24;20(1):263. doi: 10.1186/s12939-021-01605-0.
• Mazumder S, Taneja S, Dalpath SK, Gupta R, Dube B, Sinha B, Bhatia K, Yoshida S, Norheim OF, Bahl R, Sommerfelt H, Bhandari N, Martines J. Impact of community-initiated Kangaroo Mother Care on survival of low birth weight infants: study protocol for a randomized controlled trial. Trials. 2017 Jun 7;18(1):262. doi: 10.1186/s13063-017-1991-7.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: December 26, 2015
• First Submitted That Met QC Criteria: January 9, 2016
• First Posted (Estimate): January 12, 2016

Study Record Updates

• Last Update Posted (Actual): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: mortality; Kangaroo Mother Care in community
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 2015/1486/REK vest