Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-03-03 @ 2:41 PM
Study NCT ID:
NCT02653534
Status:
COMPLETED
Last Update Posted:
2018-12-07
First Post:
2015-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D060127', 'term': 'Kangaroo-Mother Care Method'}], 'ancestors': [{'id': 'D056888', 'term': 'Patient Positioning'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007224', 'term': 'Infant Care'}, {'id': 'D002654', 'term': 'Child Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8402}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-06', 'studyFirstSubmitDate': '2015-12-26', 'studyFirstSubmitQcDate': '2016-01-09', 'lastUpdatePostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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', 'description': 'Recognition of illness will be ascertained from caregivers by using questionnaire'}, {'measure': 'Early appropriate care seeking practices at 1 month', 'timeFrame': '1 month period', 'description': 'Early appropriate care seeking ascertained from caregivers by using questionnaire'}, {'measure': 'Early recognition of illness at 3 months', 'timeFrame': 'Assessed at 3 months, data from 1 month upto 3 months', 'description': 'Recognition of illness ascertained from caregivers by using questionnaire'}, {'measure': 'Early appropriate care seeking practices at 3 months', 'timeFrame': 'Assessed at 3 months, data from 1 month upto 3 months', 'description': 'Early appropriate care-seeking ascertained from caregivers by using questionnaire'}, {'measure': 'Early recognition of illness at 6 months', 'timeFrame': 'Assessed at 6 months, data from 3 months upto 6 months', 'description': 'Recognition of illness ascertained from caregivers by using questionnaire'}, {'measure': 'Early appropriate care seeking practices at 6 months', 'timeFrame': 'Assessed at 6 months, data from 3 months upto 6 months', 'description': 'Early appropriate care-seeking practices ascertained by using questionnaire'}, {'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Kangaroo Mother Care in community', 'mortality'], 'conditions': ['Low-Birth-Weight']}, 'referencesModule': {'references': [{'pmid': '35903458', 'type': 'DERIVED', '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.'}, {'pmid': '35685868', 'type': 'DERIVED', '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.'}, {'pmid': '34952592', 'type': 'DERIVED', '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.'}, {'pmid': '31590989', 'type': 'DERIVED', '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.'}, {'pmid': '28592313', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nNewborns 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.\n\nSurvival will be ascertained in all enrolled infants through contacts at 1, 3 and 6 months.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nLow birth weight babies (≥1500 to ≤2250 g) screened within 3 days and their mothers.\n\n* Born at home\n* Singleton or twins or triplets\n* Infants born in hospital, discharged and KMC not initiated in the hospital\n\nExclusion Criteria:\n\n* Infant unable to feed\n* Infant has breathing problem\n* Infant is less active than normal\n* Gross congenital malformations\n* Mother does not intend to stay in the study area for the next 6 months'}, 'identificationModule': {'nctId': 'NCT02653534', 'acronym': 'KMC-LBW', 'briefTitle': 'Impact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants', 'organization': {'class': 'OTHER', 'fullName': 'Society for Applied Studies'}, 'officialTitle': 'Impact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants', 'orgStudyIdInfo': {'id': '2015/1486/REK vest'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Kangaroo Mother Care', 'description': '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', 'interventionNames': ['Behavioral: Kangaroo Mother Care']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Routine visits by government health workers'}], 'interventions': [{'name': 'Kangaroo Mother Care', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Intervention Kangaroo Mother Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '121102', 'city': 'Palwal', 'state': 'Haryana', 'country': 'India', 'facility': 'CHRD, Society for Applied Studies', 'geoPoint': {'lat': 28.14469, 'lon': 77.32546}}], 'overallOfficials': [{'name': 'Dr. Sarmila Mazumder, MBBS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Society for Applied Studies'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Society for Applied Studies', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre For International Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}