Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-02-01 @ 1:29 PM
Study NCT ID:
NCT02143193
Status:
COMPLETED
Last Update Posted:
2018-08-23
First Post:
2014-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skin-to Skin Contact on Newborn Temperature
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2014-05-16', 'studyFirstSubmitQcDate': '2014-05-16', 'lastUpdatePostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to first breastfeeding', 'timeFrame': '30 to 90 minutes after birth'}, {'measure': 'Percentage of Weight Loss During Hospitalization', 'timeFrame': '24-72 hours'}], 'primaryOutcomes': [{'measure': 'Time to temperature stabilization until initial bath', 'timeFrame': 'one minute to 60 minutes after birth'}], 'secondaryOutcomes': [{'measure': 'Time required for temperature re-stabilization after initial bath', 'timeFrame': 'on minute after initial bath until baby reaches desired temperature'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breastfeeding', 'Newborn', 'Formula', 'Temperature', 'Initial Bath'], 'conditions': ['Pregnancy', 'Skin to Skin Contact']}, 'descriptionModule': {'briefSummary': "This study will compare standard methods of stabilizing a newborn's temperature after birth with mother-infant skin-to-skin contact for stabilizing newborn temperature. The study will look at the effects of each warming method on the timing of newborns' initial bath and the effects on newborn initiation and percent weight loss by discharge.\n\nThe study will use a randomized controlled trial (RCT) design to test a clinical intervention at TriHealth Good Samaritan Hospital. Study participants will be randomized to the intervention group (IG), which will implement mother-baby Skin-to-Skin (STS) immediately after vaginal birth, or to the control group (CG), which will receive standard care for newborn and mother immediately after vaginal birth.\n\nThis study will test the hypothesis that mother-baby STS contact implemented immediately after delivery for a minimum of the newborn's first 60 minutes and with a resumption of STS (if a 15-minute break in STS occurs at some point after the first hour) until the newborn's temperature stabilizes after the initial bath will result in:\n\n1. Improved newborn temperature stability and thermoregulation for newborns whether breast or formula-fed.\n2. Initiation of effective breastfeeding behavior within 90 minutes of birth and the addition of at least one more breastfeeding within four hours of birth for breastfed newborns.\n3. Avoidance of newborn weight loss of 10% or greater."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman in labor presenting with\n* An uncomplicated pregnancy\n* Full-term gestation: 38 0/7 weeks\n* Single gestation\n* Vertex presentation\n* Plans to deliver without general anesthesia\n* Likelihood of a vaginal delivery\n\nExclusion Criteria:\n\n* A complication of pregnancy at the time of admission\n* An inability to speak or understand English language\n* Preterm gestation: 37 6/7 weeks\n* A multiple gestation\n* Non-vertex presentation\n* Plan for delivery with general anesthesia\n* Planned Cesarean delivery'}, 'identificationModule': {'nctId': 'NCT02143193', 'briefTitle': 'Skin-to Skin Contact on Newborn Temperature', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'The Effects of Skin-to-Skin Contact on Newborn Temperature, Initial Bath and Early Breastfeefing', 'orgStudyIdInfo': {'id': '11082-11-058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Skin to Skin Contact', 'description': 'implement mother-baby Skin-to-Skin contact immediately after vaginal birth', 'interventionNames': ['Behavioral: Skin-to-Skin Contact']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'standard care for newborn and mother immediately after vaginal birth'}], 'interventions': [{'name': 'Skin-to-Skin Contact', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Skin to Skin Contact']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Good Samaritan TriHealth Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Karen Gromada, MSN, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TriHealth Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rachel Baker', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Nurse Researcher', 'investigatorFullName': 'Rachel Baker', 'investigatorAffiliation': 'TriHealth Inc.'}}}}