Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-02-05 @ 8:59 AM
Study NCT ID:
NCT00531492
Status:
COMPLETED
Last Update Posted:
2011-12-12
First Post:
2007-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Continuous Skin to Skin Care (Technique Kangaroo: TK) After Birth for Low Birth Weight (LBW) Infants and Their Mothers in Developing Countries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-08', 'studyFirstSubmitDate': '2007-09-17', 'studyFirstSubmitQcDate': '2007-09-17', 'lastUpdatePostDateStruct': {'date': '2011-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality within 28 days after birth', 'timeFrame': 'within 28 days after birth'}], 'secondaryOutcomes': [{'measure': 'Mobility within 28 days after birth', 'timeFrame': 'within 28 days after birth'}, {'measure': 'Mortality and Mobility within 28 days after birth', 'timeFrame': 'within 28 days after birth'}, {'measure': "Difference of (Baby's) loss in weight within 2 days", 'timeFrame': 'within 2 days'}, {'measure': "Difference of (Baby's) Body weight of 14th day after birth", 'timeFrame': '14th day after birth'}, {'measure': "Difference of (Baby's) Body weight of 28th day after birth", 'timeFrame': '28th day after birth'}, {'measure': 'Incidence of hypothermia during hospitalisation and (or) during outpatient department （lower than 35.5℃）', 'timeFrame': 'Within 28 days after birth'}, {'measure': 'Incidence of bradycardia or tachycardia during hospitalisation (HR <100, or>180 /min)', 'timeFrame': 'within 28 days after birth'}, {'measure': 'Incidence of apnea during hospitalisation (> 20 sec)', 'timeFrame': 'within 28 days after birth'}, {'measure': 'Incidence of desaturation during hospitalisation ( <87%)', 'timeFrame': 'within 28 days after birth'}, {'measure': 'Length of hospitalisation', 'timeFrame': 'within 28 days after birth'}, {'measure': 'Discharge within 7days after birth', 'timeFrame': 'within 7days after birth'}, {'measure': 'Mobility within 6 months or 1 year after birth', 'timeFrame': 'within 6 months or 1 year'}, {'measure': 'Mortality and Morbility within 6 months or 1 year after birth', 'timeFrame': 'within 6 months or 1 year'}, {'measure': 'Mortality within 6 months or 1 year after birth', 'timeFrame': 'within 6 months or 1 year'}, {'measure': 'Incidence of hyperthermia during hospitalisation and (or) outpatient department （upper than 37.5℃）', 'timeFrame': 'Within 28 days after birth'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Maternal and child health', 'Developing country', 'Skin to skin care', 'Newly born low birth weight infants and their mothers', '(Delivery at University Hospital Center, Mahajanga, Madagascar)'], 'conditions': ['Low Birth Weight']}, 'referencesModule': {'references': [{'pmid': '20121708', 'type': 'RESULT', 'citation': 'Nagai S, Andrianarimanana D, Rabesandratana N, Yonemoto N, Nakayama T, Mori R. Earlier versus later continuous Kangaroo Mother Care (KMC) for stable low-birth-weight infants: a randomized controlled trial. Acta Paediatr. 2010 Jun;99(6):827-35. doi: 10.1111/j.1651-2227.2009.01676.x. Epub 2010 Jan 27.'}, {'pmid': '21635363', 'type': 'RESULT', 'citation': 'Nagai S, Yonemoto N, Rabesandratana N, Andrianarimanana D, Nakayama T, Mori R. Long-term effects of earlier initiated continuous Kangaroo Mother Care (KMC) for low-birth-weight (LBW) infants in Madagascar. Acta Paediatr. 2011 Dec;100(12):e241-7. doi: 10.1111/j.1651-2227.2011.02372.x. Epub 2011 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the efficacy of Technique Kangourou (TK) between low birth weight (LBW) infants and their mothers started as soon as possible within 24 hours after birth in developing country.\n\nFor the purpose of this study, TK is defined as skin-to-skin direct and continuous (24 hours) contact between LBW infants and their mothers or any other people who substitute mothers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Birth weight (BW) \\< 2500g\n* Delivery at maternity of CHUM (Birth \\< 24 hours)\n* Without serious congenital malformation\n* Sat O2 \\>=95％, HR \\> 100 / min, RR \\< 60 / min, Capillary refilling time \\< 3 sec\n* The mother and the family are motivated to practice TK.\n* The mother and the family available to practise TK should be healthy.\n\nExclusion Criteria:\n\n* Apnea of prematurity \\>20 sec\n* With intravenous infusion'}, 'identificationModule': {'nctId': 'NCT00531492', 'acronym': 'EtudeTK', 'briefTitle': 'Efficacy of Continuous Skin to Skin Care (Technique Kangaroo: TK) After Birth for Low Birth Weight (LBW) Infants and Their Mothers in Developing Countries', 'organization': {'class': 'OTHER', 'fullName': 'Foundation for Advanced Studies on International Development'}, 'officialTitle': 'Randomized Controlled Trial of Continuous Skin to Skin Care (Technique Kangourou: TK) for Low Birth Weight (LBW) Infants and Their Mothers at University Hospital Center of Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM), Madagascar', 'orgStudyIdInfo': {'id': 'FASID-06-CE-56'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Behavioral: TK as soon as possible within 24 hours after birth']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Other: Conventional care']}], 'interventions': [{'name': 'TK as soon as possible within 24 hours after birth', 'type': 'BEHAVIORAL', 'description': 'Start TK as soon as possible within 24 hours after birth', 'armGroupLabels': ['A']}, {'name': 'Conventional care', 'type': 'OTHER', 'description': 'Start conventional care (At first use incubator, and start TK when the infants and mother are completely settled and ready)', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mahajanga', 'state': 'Mahajanga', 'country': 'Madagascar', 'facility': 'University Hospital Center of Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM),', 'geoPoint': {'lat': -15.71667, 'lon': 46.31667}}], 'overallOfficials': [{'name': 'Shuko Nagai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Groupe d'Etude de la Technique Kangourouà Mahajanga, Madagascar"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation for Advanced Studies on International Development', 'class': 'OTHER'}, 'collaborators': [{'name': "St.Luke's Life Science Institute, Tokyo, Japan", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Groupe d'Etude de la Technique Kangourouà", 'investigatorFullName': 'Shuko Nagai', 'investigatorAffiliation': 'Foundation for Advanced Studies on International Development'}}}}