Clinical trial NCT02631343: Community Kangaroo Mother Care for Improving Child Survival and Brain Development in Low Birth Weight Newborns
Official title: A Community-based Model of Delivery of Kangaroo Mother Care for Improving Child Survival and Brain Development in Low Birth Weight Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Birth Weight
Keywords: Kangaroo mother care in the community
Lead sponsor: Society for Applied Studies
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
First posted: 2015-12-16
Enrollment: 550
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of maternal depression
timeFrame: 6 weeks
measure: Assessment of maternal depression
timeFrame: Assessment of maternal depression at 6 months
measure: Assessment of maternal sense of competence
timeFrame: 6 weeks
measure: Assessment of maternal sense of competence
timeFrame: Assessment of maternal sense of competence at 12 months
measure: Assessment of mother infant bonding
timeFrame: 6 weeks
measure: Assessment of mother infant interaction
timeFrame: 6 months
measure: Assessment of newborn behaviour
timeFrame: 6 weeks
measure: Assessment of infant temperament
timeFrame: 6 months
measure: Assessment of infant temperament
timeFrame: Assessment of infant temperament at 12 months
measure: Assessment of cognitive function by Bayley scale
timeFrame: 6 months
measure: Assessment of cognitive function by Bayley scale
timeFrame: Assessment of cognitive function by Bayley scale at 12 months
measure: Assessment of home environment by PROCESS
timeFrame: 12 months
Secondary outcomes:
measure: Neonatal mortality
timeFrame: From birth to 28 days
measure: Early infant mortality
timeFrame: From birth to 6 months
measure: Early initiation of breastfeeding
timeFrame: From birth to 1 month
measure: Proportion exclusively breastfed
timeFrame: 1, 3 and 6 months
measure: Weight and length gain
timeFrame: 1, 3, 6 and 12 months
measure: Incidence of infection in neonatal
timeFrame: 1 month period
measure: Early recognition of illness at 1 month
timeFrame: 1 month period
measure: Early and appropriate care seeking practices at 1 month
timeFrame: 1 month period
measure: Early recognition of illness at 3 months
timeFrame: Assessed at 3 months data from 1 month upto 3 months
measure: Early and appropriate care seeking practices at 3 months
timeFrame: Assessed at 3 months data from 1 month upto 3 months
measure: Early recognition of illness at 6 months
timeFrame: Assessed at 6 months data from 3 months upto 6 months
measure: Early and appropriate care seeking practices at 6 months
timeFrame: Assessed at 6 months data from 3 months upto 6 months
Other outcomes:
Locations:
city: Palwal
country: India
facility: CHRD, Society for Applied Studies
state: Haryana
Study officials:
affiliation: Centre for Health Research and Development, Society for Applied Studies
name: Sunita Taneja, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.