Community Kangaroo Mother Care for Improving Child Survival and Brain Development in Low Birth Weight Newborns (CKMC-DEV)

A Community-based Model of Delivery of Kangaroo Mother Care for Improving Child Survival and Brain Development in Low Birth Weight Newborns

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.

Study Overview

• Status: Completed
• Conditions: Low Birth Weight
• Intervention / Treatment: Behavioral: KMC; Other: Essential newborn care

Detailed Description

Low birth weight (LBW) infants will be identified through surveillance. Eligible infants will be randomized into the intervention and control groups. Mother in the intervention group will be supported by a ANM-like study workers assisted by ASHA-like study workers to provide Kangaroo mother care (KMC) to their babies at home. Breastfeeding support will also be provided to these mothers by ANM-like study workers. Essential newborn care will be delivered through Government workers in both groups. Survival will be measured in all enrolled infants through contacts at 1, 3, 6 and 12 months of age. Information will also be ascertained on initiation of breastfeeding, exclusive breastfeeding rates, incidence of infection in the neonatal and in the 1-5 months period. Development outcomes (Maternal Depression, Maternal sense of competence, Mother-infant Bonding, Mother-infant interaction, Newborn Behaviour, Infant temperament, Brain development) will be measured at enrolment, 6weeks, 6 and 12 months of age. Growth will be measured at enrolment and at 1, 3, 6 and 12 months.

• Study Type: Interventional
• Enrollment (Actual): 550
• 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

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

Exclusion criteria

• 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

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 KMC; 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: KMC; 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; Other: Essential newborn care
Other: Control; Routine visits by government health workers	Other: Essential newborn care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incidence of infection in neonatal		1 month period
Early recognition of illness at 1 month	Recognition of illness and careseeking will be ascertained from caregivers by using questionnaires	1 month period
Early and appropriate care seeking practices at 1 month	Early and appropriate care seeking ascertained from caregivers by using questionnaires	1 month period
Early recognition of illness at 3 months		Assessed at 3 months data from 1 month upto 3 months
Early and appropriate care seeking practices at 3 months		Assessed at 3 months data from 1 month upto 3 months
Early recognition of illness at 6 months		Assessed at 6 months data from 3 months upto 6 months
Early and appropriate care seeking practices at 6 months		Assessed at 6 months data from 3 months upto 6 months

Collaborators and Investigators

• Sponsor: Society for Applied Studies
• Collaborators: Grand Challenges Canada
• Investigators: Principal Investigator: Sunita Taneja, MBBS, PhD, Centre for Health Research and Development, Society for Applied Studies

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: November 25, 2015
• First Submitted That Met QC Criteria: December 11, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Kangaroo mother care in the community
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 0725-03