Clinical trial NCT02653534: Impact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants
Official title: Impact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low-Birth-Weight
Keywords: Kangaroo Mother Care in community
mortality
Lead sponsor: Society for Applied Studies
Sponsor class: OTHER
Collaborators: name: Centre For International Health
First posted: 2016-01-12
Enrollment: 8402
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Neonatal mortality from post enrolment to 28 days
timeFrame: From post enrolment to 28 days
measure: Early infant mortality from post enrolment to 6 months of age
timeFrame: From post enrolment to 6 months
Secondary outcomes:
measure: Proportion exclusively breastfed at 1 and 3 months
timeFrame: 1 month, 3 months
measure: Weight gain
timeFrame: 1, 3 and 6 months
measure: Length gain
timeFrame: 1, 3 and 6 months
measure: Incidence of infection and hospitalization
timeFrame: 1 month and 1 to 5 months
measure: Early recognition of illness at 1 month
timeFrame: 1 month period
measure: Early 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 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 appropriate care seeking practices at 6 months
timeFrame: Assessed at 6 months, data from 3 months upto 6 months
measure: Assessment of cognitive function by Bayley scale in a subsample
timeFrame: Assessment of cognitive function by Bayley scale at 6 months
measure: Assessment of cognitive function by Bayley scale in a subsample
timeFrame: Assessment of cognitive function by Bayley scale at 12 months
measure: Head circumference
timeFrame: 1, 3 and 6 months
Other outcomes:
Locations:
city: Palwal
country: India
facility: CHRD, Society for Applied Studies
state: Haryana
Study officials:
affiliation: Society for Applied Studies
name: Dr. Sarmila Mazumder, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.