NCT02631343

Brief Summary

While newborn and child survival remains a priority, optimal development of survivors is receiving increasing attention. Interventions that impact both survival and development should be prioritized for action. Kangaroo Mother Care (KMC) improves survival, and potentially neurodevelopment, in preterm and low birth weight infants in hospital settings but its coverage remains low. Innovation is required to allow the community-based delivery of KMC by front-line workers. This could greatly accelerate scale up and sustainability of this intervention in low resource settings. The proposed randomized trial is planned in a setting where 40% of births take place at home. Early discharge (as early as within 12 hours of birth) is common for facility births, often at the request of families for social and cultural reasons. Many of the hospitals do not have incubators for the care of very small babies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

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
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

1.5 years

First QC Date

November 25, 2015

Last Update Submit

September 5, 2018

Conditions

Low Birth Weight

Keywords

Kangaroo mother care in the community

Outcome Measures

Primary Outcomes (12)

  • Assessment of maternal depression

    The depression will be measured using patient health questionnaire-9

    6 weeks

  • Assessment of maternal depression

    The depression will be measured using patient health questionnaire-9

    Assessment of maternal depression at 6 months

  • Assessment of maternal sense of competence

    Maternal sense of competence will be measured by maternal self efficacy questionnaire

    6 weeks

  • Assessment of maternal sense of competence

    Maternal sense of competence will be measured by maternal self efficacy questionnaire

    Assessment of maternal sense of competence at 12 months

  • Assessment of mother infant bonding

    Mother infant bonding will be measured by maternal postnatal attachment questionnaire

    6 weeks

  • Assessment of mother infant interaction

    Mother infant interaction will be assessed by video recording and subsequent coding of Joint attention task

    6 months

  • Assessment of newborn behaviour

    Assessment of newborn behaviour by Neonatal behavioural assessment scale

    6 weeks

  • Assessment of infant temperament

    Assessment of infant temperament by infant temperament scale

    6 months

  • Assessment of infant temperament

    Assessment of infant temperament by infant temperament scale

    Assessment of infant temperament at 12 months

  • Assessment of cognitive function by Bayley scale

    6 months

  • Assessment of cognitive function by Bayley scale

    Assessment of cognitive function by Bayley scale at 12 months

  • Assessment of home environment by PROCESS

    12 months

Secondary Outcomes (12)

  • Neonatal mortality

    From birth to 28 days

  • Early infant mortality

    From birth to 6 months

  • Early initiation of breastfeeding

    From birth to 1 month

  • Proportion exclusively breastfed

    1, 3 and 6 months

  • Weight and length gain

    1, 3, 6 and 12 months

  • +7 more secondary outcomes

Study Arms (2)

Intervention KMC

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: KMCOther: Essential newborn care

Control

OTHER

Routine visits by government health workers

Other: Essential newborn care

Interventions

KMCBEHAVIORAL

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 KMC
Essential newborn careOTHER
ControlIntervention KMC

Eligibility Criteria

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

You may qualify if:

  • \- Mothers and low birth weight ≥1500gms to ≤2250gms

You may not qualify if:

  • Birth weight \<1500gms
  • Unable to feed on offering feeds, confirmed by study team
  • Infant has breathing problems or less active
  • Mother does not intend to stay in study area for the next 12 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 (3)

  • Upadhyay RP, Taneja S, Strand TA, Sommerfelt H, Hysing M, Mazumder S, Bhandari N, Martines J, Dua T, Kariger P, Bahl R. Early child stimulation, linear growth and neurodevelopment in low birth weight infants. BMC Pediatr. 2022 Oct 8;22(1):586. doi: 10.1186/s12887-022-03579-6.

    PMID: 36209050DERIVED

  • Taneja S, Sinha B, Upadhyay RP, Mazumder S, Sommerfelt H, Martines J, Dalpath SK, Gupta R, Kariger P, Bahl R, Bhandari N, Dua T; ciKMC development study group. Community initiated kangaroo mother care and early child development in low birth weight infants in India-a randomized controlled trial. BMC Pediatr. 2020 Apr 4;20(1):150. doi: 10.1186/s12887-020-02046-4.

    PMID: 32247311DERIVED

  • 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

Study Officials

  • Sunita Taneja, MBBS, PhD

    Centre for Health Research and Development, 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

November 25, 2015

First Posted

December 16, 2015

Study Start

November 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

September 7, 2018

Record last verified: 2018-09

Locations

IN(1)