Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-02-24 @ 1:15 AM
Study NCT ID:
NCT03741803
Status:
SUSPENDED
Last Update Posted:
2024-05-08
First Post:
2018-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051556', 'term': 'Hyperbilirubinemia, Neonatal'}, {'id': 'D007567', 'term': 'Jaundice, Neonatal'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000087526', 'term': 'Umbilical Cord Clamping'}], 'ancestors': [{'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'whyStopped': 'Study paused due to COVID-19 and personnel', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2018-11-12', 'studyFirstSubmitQcDate': '2018-11-12', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonatal bilirubin level', 'timeFrame': '24 hours after birth'}], 'secondaryOutcomes': [{'measure': 'Number of neonates with hyperbilirubinemia', 'timeFrame': '24 hours after birth', 'description': 'Hyperbilirubinemia is a condition in which there is too much bilirubin in the blood.'}, {'measure': 'Number of neonates with a need for phototherapy', 'timeFrame': 'From birth to up to 1 week after birth'}, {'measure': 'Number of neonates with a need for exchange transfusion', 'timeFrame': 'From birth to up to 1 week after birth'}, {'measure': 'Number of neonates admitted to the neonatal intensive care unit (NICU)', 'timeFrame': 'From birth to up to 1 week after birth'}, {'measure': 'Number of mothers with postpartum hemorrhage', 'timeFrame': 'From birth to up to 1 week after birth'}, {'measure': 'Number of neonates re-hospitalized for jaundice', 'timeFrame': 'From birth to up to 1 week after birth'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperbilirubinemia, Neonatal', 'Jaundice, Neonatal']}, 'descriptionModule': {'briefSummary': "The purpose of the study is to determine if neonates (who already have an increased risk of hyperbilirubinemia due to mother's history of having previous neonate who received phototherapy for hyperbilirubinemia) have higher bilirubin levels 24 hours after birth with delayed cord clamping."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mothers delivering at 35 weeks or greater\n* mothers who have had at least 1 previous child that received phototherapy for hyperbilirubinemia\n* multiple gestations can be included unless the neonate does not meet criteria for delayed cord clamping as described below or due to concerns about safety of delayed cord clamping for timing of delivery of the 2nd twin (ie: 2nd twin requires immediate delivery intervention)\n\nExclusion Criteria:\n\n\\- Neonates who do not meet criteria for delayed cord clamping (any infant that any provider in the room felt needed evaluation by the neonatal transport team immediately so that the infant would be handed off for resuscitation. If the patient required delivery by cesarean section the delayed cord clamping protocol would be abandoned).'}, 'identificationModule': {'nctId': 'NCT03741803', 'briefTitle': 'Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Randomized Controlled Trial to Evaluate the Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice', 'orgStudyIdInfo': {'id': 'HSC-MS-17-0803'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed cord clamping', 'interventionNames': ['Procedure: Delayed cord clamping']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Early cord clamping', 'interventionNames': ['Procedure: Early cord clamping']}], 'interventions': [{'name': 'Delayed cord clamping', 'type': 'PROCEDURE', 'description': 'The umbilical cord will be clamped after 60 seconds after birth', 'armGroupLabels': ['Delayed cord clamping']}, {'name': 'Early cord clamping', 'type': 'PROCEDURE', 'description': 'The umbilical cord will be clamped as soon as feasible after birth, usually within the initial 15 seconds after birth.', 'armGroupLabels': ['Early cord clamping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Pamela D Berens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pamela Berens', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}