Impact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants
NCT ID: NCT02653534
Last Updated: 2018-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
8402 participants
INTERVENTIONAL
2015-11-30
2018-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention Kangaroo Mother Care
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
Kangaroo Mother Care
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
Control
Routine visits by government health workers
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Kangaroo Mother Care
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Born at home
* Singleton or twins or triplets
* Infants born in hospital, discharged and KMC not initiated in the hospital
Exclusion Criteria
* 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
3 Days
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre For International Health
OTHER
Society for Applied Studies
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dr. Sarmila Mazumder, MBBS, PhD
Role: PRINCIPAL_INVESTIGATOR
Society for Applied Studies
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHRD, Society for Applied Studies
Palwal, Haryana, India
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015/1486/REK vest
Identifier Type: -
Identifier Source: org_study_id