NCT02653534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,402

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

December 7, 2018

Status Verified

December 1, 2015

Enrollment Period

2.9 years

First QC Date

December 26, 2015

Last Update Submit

December 6, 2018

Conditions

Low-Birth-Weight

Keywords

Kangaroo Mother Care in communitymortality

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (13)

  • 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

    1 month period

  • +8 more secondary outcomes

Study Arms (2)

Intervention Kangaroo Mother Care

EXPERIMENTAL

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

Control

NO INTERVENTION

Routine visits by government health workers

Interventions

Kangaroo Mother CareBEHAVIORAL

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

Intervention Kangaroo Mother Care

Eligibility Criteria

AgeUp to 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRD, Society for Applied Studies

Palwal, Haryana, 121102, India

Location

Related Publications (5)

  • 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.

    PMID: 35903458DERIVED

  • 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.

    PMID: 35685868DERIVED

  • 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.

    PMID: 34952592DERIVED

  • 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.

    PMID: 31590989DERIVED

  • 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.

    PMID: 28592313DERIVED

MeSH Terms

Interventions

Kangaroo-Mother Care Method

Intervention Hierarchy (Ancestors)

Patient PositioningPatient CareTherapeuticsInfant CareChild CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Dr. Sarmila Mazumder, MBBS, PhD

    Society for Applied Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2015

First Posted

January 12, 2016

Study Start

November 1, 2015

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

December 7, 2018

Record last verified: 2015-12

Locations

IN(1)