Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-31 @ 3:58 AM
Study NCT ID:
NCT01819532
Status:
TERMINATED
Last Update Posted:
2017-12-11
First Post:
2011-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'extremely poor recruitment \\& since the study was approved, medical practice has evolved to where cord milking is now common practice.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-07', 'studyFirstSubmitDate': '2011-10-06', 'studyFirstSubmitQcDate': '2013-03-22', 'lastUpdatePostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin during NICU course', 'timeFrame': 'within 24 hours of birth and through NICU stay'}], 'secondaryOutcomes': [{'measure': '1-min Apgar', 'timeFrame': 'at 1 minute of life'}, {'measure': '5 min Apgar', 'timeFrame': 'at 5 minutes of life'}, {'measure': 'Blood Sugar upon admission to NICU', 'timeFrame': 'within 1 hour of birth'}, {'measure': 'Temperature on admission to NICU', 'timeFrame': 'within 1 hour of birth'}, {'measure': 'Cord blood pH', 'timeFrame': 'within 1 hour of birth'}, {'measure': 'Blood pressure upon admission to NICU', 'timeFrame': 'within 1 hour of birth'}, {'measure': 'Number of volume challenges in first 24 hours of life', 'timeFrame': 'at 24 hours of birth'}, {'measure': 'Days requiring ventilation', 'timeFrame': '2 months'}, {'measure': 'Neonatal death', 'timeFrame': '6 months'}, {'measure': 'Length of hospital stay', 'timeFrame': '6 months'}, {'measure': 'Intraventricular hemorrhage', 'timeFrame': '6 months'}, {'measure': 'Number and volume of blood transfusions', 'timeFrame': '10 units'}, {'measure': 'duration of phototherapy', 'timeFrame': '1 month'}, {'measure': 'Maximum serum bilirubin', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neonate', 'umbilical cord', 'cord milking', 'prematurity'], 'conditions': ['Prematurity']}, 'descriptionModule': {'briefSummary': 'Anemia in preterm neonates is a significant problem encountered frequently in the neonatal intensive care unit. Most preterm neonates born at less than 33 weeks gestation will require at least one blood transfusion during their hospital course and many will require repeated transfusions. Blood transfusions, albeit necessary, carry increased risk of viral infections and transfusion reactions as well as increase the cost of healthcare. The umbilical cord and placenta harbor up to 40% of blood available during fetal life. The current standard of care is immediate umbilical cord clamping. The investigators are performing a randomized controlled trial comparing immediate cord clamping to milking the umbilical cord prior to clamping in neonate born preterm less than 33 weeks gestation. The investigators hypothesize that milking the umbilical cord will demonstrate the same benefits as delayed cord clamping, without delaying neonatal resuscitation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm neonates delivered between 24 0/7 and 32 6/7\n* Mother carrying a fetus between 24-32 6/7 weeks estimated gestational age\n* Written parental consent\n\nExclusion Criteria:\n\n* Multiple gestation pregnancies (twins or higher order multiples)\n* Rh or other antibody sensitization\n* Hydrops fetalis\n* Known major congenital abnormality\n* Suspected abruptio placentae'}, 'identificationModule': {'nctId': 'NCT01819532', 'briefTitle': 'Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants <33 Weeks: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NA_00046760'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate umbilical cord clamping', 'description': 'The umbilical cord will be clamped immediately after delivery.', 'interventionNames': ['Procedure: Immediate cord clamping']}, {'type': 'EXPERIMENTAL', 'label': 'Cord milking group', 'description': 'The umbilical cord will be "milked" in direction towards neonate 4 times over the course of 10 minutes.', 'interventionNames': ['Procedure: Milking group']}], 'interventions': [{'name': 'Milking group', 'type': 'PROCEDURE', 'description': 'The umbilical cord will be "milked" toward the neonate four times prior to clamping the umbilical cord.', 'armGroupLabels': ['Cord milking group']}, {'name': 'Immediate cord clamping', 'type': 'PROCEDURE', 'description': 'The umbilical cord will be clamped and cut immediately after delivery of the neonate.', 'armGroupLabels': ['Immediate umbilical cord clamping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Jessica Bienstock, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}