Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-07 @ 5:39 AM
Study NCT ID:
NCT05505903
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2021-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Duration Since Birth Until Admission to Well-baby Nursery on Neonatal Temperature at Admission
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2412}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-10', 'studyFirstSubmitDate': '2021-10-04', 'studyFirstSubmitQcDate': '2022-08-17', 'lastUpdatePostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Temperature', 'timeFrame': '1 year', 'description': 'The temperature upon admission to WBN or NICU'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypothermia', 'friendly Cesarean section'], 'conditions': ['Hypothermia, Newborn']}, 'descriptionModule': {'briefSummary': 'The investigators will collect the time interval from birth to arrival to WBN or NICU, the time interval from arrival to nurse admission, the first measured temperature, and the week of birth.\n\nThe investigators will divide the newborn infants to three groups: infants born vaginally, infants born by regular Cesarean section, and infants born by friendly Cesarean section, and compare the groups.', 'detailedDescription': "Introduction Friendly Cesarean section mimics normal vaginal delivery as the newborn is put on mother's chest immediately after delivery and cutting the umbilical cord, and the mother even breastfeeds the newborn infant, if she wishes to. Friendly Cesarean section is offered to the mother if there are no contraindications, such as general anesthesia, fetal distress, or prematurity. Skin to skin contacts lasts for several minutes, as long as the mothers wish to, and depend on mothers' medical state, and newborns' medical state.\n\nIn friendly Cesarean section, the skin to skin contact technique includes putting the newborn on mother's chest, and covering them both by a blanket. Yet, during Cesarean section the mother is covered by a thin paper-like sterile sheet, and as the temperature in operating room is low, her skin cools gradually from the spinal anesthesia until actually delivering the newborn infant. So, although the newborn infant is put on the mother's chest and covered by a blanket, there is a possibility for it to develop hypothermia.\n\nLiterature about this issue is rare, so the investigators conducted a study to check this possibility.\n\nMethods In Hillel Yaffe medical center nurses measure infants temperature on admission to well-baby nursery (WBN) or neonatal intensive care unit (NICU). Admission is not always performed on arrival, due to other nurse-tasks, such as other newborn infants treatment, or breastfeeding education.\n\nThe most measureable piece of data that characterize friendly Cesarean section is the longer time interval from the birth until arrival to WBN or NICU.\n\nInclusion criteria: infants born within the time study interval. Exclusion criteria: infants born at less than complete 35 gestational weeks, since there is no for offer friendly Cesarean section for these births.\n\nThe investigators will collect the time interval from birth to arrival to WBN or NICU, the time interval from arrival to nurse admission, the first measured temperature, and the week of birth.\n\nThe investigators will divide the newborn infants to three groups: infants born vaginally, infants born by regular Cesarean section, and infants born by friendly Cesarean section, and compare the groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Hours', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants born at Hillel Yaffe meducal center', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all newborn infants\n\nExclusion Criteria:\n\n* infants born after less than 35 complete gestational weeks'}, 'identificationModule': {'nctId': 'NCT05505903', 'briefTitle': 'Influence of Duration Since Birth Until Admission to Well-baby Nursery on Neonatal Temperature at Admission', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Influence of Duration Since Birth Until Admission to Well-baby Nursery on Neonatal Temperature at Admission', 'orgStudyIdInfo': {'id': '0032-22-HYMC-IL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vaginal delivery', 'description': 'Newborn Infants born by vaginal delivery.', 'interventionNames': ['Diagnostic Test: Temerature measurement']}, {'label': 'Regular Cesarean section', 'description': 'Newborn infants born by regular Cesarean section', 'interventionNames': ['Diagnostic Test: Temerature measurement']}, {'label': 'Friendly Cesarean section', 'description': 'Newborn infants born by friendly Cesarean section', 'interventionNames': ['Diagnostic Test: Temerature measurement']}], 'interventions': [{'name': 'Temerature measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'Temerature measurement on admission to WBN or NICU', 'armGroupLabels': ['Friendly Cesarean section', 'Regular Cesarean section', 'Vaginal delivery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'facility': 'Neonatal intensive care unit, Hillel Yaffe medical center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'overallOfficials': [{'name': 'Erez Nadir, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hille Yaffe medical center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Erez Nadir, MD', 'investigatorAffiliation': 'Hillel Yaffe Medical Center'}}}}