Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-27 @ 3:45 AM
Study NCT ID:
NCT03916159
Status:
COMPLETED
Last Update Posted:
2023-11-08
First Post:
2019-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extrauterine Placental Transfusion In Neonatal Resuscitation Of Very Low Birth Weight Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005330', 'term': 'Fetofetal Transfusion'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D000751', 'term': 'Anemia, Neonatal'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000087526', 'term': 'Umbilical Cord Clamping'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-06', 'studyFirstSubmitDate': '2019-04-05', 'studyFirstSubmitQcDate': '2019-04-12', 'lastUpdatePostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hematocrit', 'timeFrame': '0 - 24 hours of life', 'description': 'Mean Hematocrit in the first 24 hours of life'}], 'secondaryOutcomes': [{'measure': 'Cerebral tissue oxygen saturation', 'timeFrame': 'During first hour of life', 'description': 'Transcutaneous measured cerebral tissue oxygen saturation given in percent (%) during neonatal resuscitation'}, {'measure': 'Mean airway pressure', 'timeFrame': 'During first hour of life', 'description': 'Mean airway pressure given in cmH2O during neonatal resuscitation'}, {'measure': 'Mean tidal volume', 'timeFrame': 'During first hour of life', 'description': 'Mean tidal volume given in milliliter (ml) during neonatal resuscitation'}, {'measure': 'Heart rate', 'timeFrame': 'During first hour of life', 'description': 'Heart rate given in beats-per-minute (bpm) during neonatal resuscitation'}, {'measure': 'Blood oxygen saturation', 'timeFrame': 'During first hour of life', 'description': 'Transcutaneous measured blood oxygen saturation given in percent (%) during neonatal resuscitation'}, {'measure': 'Admission temperature', 'timeFrame': 'Admission to ward is up to 120 minutes of age', 'description': 'Mean temperature at admission'}, {'measure': 'All Grade Intraventricular Hemorrhage (IVH)', 'timeFrame': 'Up to 28 days of life', 'description': 'Incidence of any intraventricular hemorrhage (grades 1-4)'}, {'measure': 'All Grade BPD', 'timeFrame': 'At the corrected age of 36 weeks', 'description': 'Incidence of Bronchopulmonary Disease (BPD) (all grades)'}, {'measure': 'Spontaneous Pneumothorax/Pneumoperitoneum', 'timeFrame': 'During the first 7 days of life', 'description': 'Early incidence of spontaneous pneumothorax and/or pneumoperitoneum'}, {'measure': 'Spontaneous Pneumothorax/Pneumoperitoneum', 'timeFrame': 'Between day 7 and day 28 of life', 'description': 'Late incidence of spontaneous pneumothorax and/or pneumoperitoneum'}, {'measure': 'NEC/SIP with surgery', 'timeFrame': 'During the first 28 days of life', 'description': 'Incidence of necrotizing enterocolitis (NEC) and/or spontaneous intestinal perforation (SIP) with need for surgery'}, {'measure': 'Retinopathy of Prematurity (ROP), higher grades', 'timeFrame': 'At the corrected age of 40 weeks', 'description': 'Incidence of retinopathy of prematurity with treatment (drugs and/or surgery)'}, {'measure': 'Death', 'timeFrame': 'Until corrected age of 40 weeks', 'description': 'Incidence of death in studied infants'}, {'measure': 'Number of participants who received red blood cell (RBC) transfusion', 'timeFrame': 'During the first 7 days of life', 'description': 'Amount of RBC Transfusion \\[cumulative ml/kg over the first 7 days\\] in those participants who received RBC transfusion'}, {'measure': 'Hyperbilirubinemia', 'timeFrame': 'During the first 14 days of life', 'description': 'Peak bilirubin concentration'}, {'measure': 'Blood Exchange Transfusion', 'timeFrame': 'During the first 14 days of life', 'description': 'Incidence of blood exchange transfusion due to critical hyperbilirubinemia of the neonate.'}, {'measure': 'Intubation and Mechanical Ventilation', 'timeFrame': 'During the first 72 hours of life', 'description': 'Incidence of intubation and time duration of mechanical ventilation'}, {'measure': 'Intubation and Mechanical Ventilation', 'timeFrame': 'During hospitalization', 'description': 'Incidence of intubation and time duration of mechanical ventilation'}, {'measure': 'Neurodevelopmental Outcome', 'timeFrame': '22-26 month corrected gestational age', 'description': 'Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III) composite score (motor, cognitive, language)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['extrauterine placental transfusion', 'delayed cord clamping', 'neonatal resuscitation'], 'conditions': ['Very Low Birth Weight Infant', 'Placental Transfusion', 'Anemia']}, 'referencesModule': {'references': [{'pmid': '31988958', 'type': 'BACKGROUND', 'citation': 'Kuehne B, Kirchgaessner C, Becker I, Kuckelkorn M, Valter M, Kribs A, Oberthuer A. Mask Continuous Positive Airway Pressure Therapy with Simultaneous Extrauterine Placental Transfusion for Resuscitation of Preterm Infants - A Preliminary Study. Biomed Hub. 2018 Jun 26;3(2):1-10. doi: 10.1159/000488926. eCollection 2018 May-Aug.'}, {'pmid': '37921769', 'type': 'RESULT', 'citation': 'Kuehne B, Gruttner B, Hellmich M, Hero B, Kribs A, Oberthuer A. Extrauterine Placental Perfusion and Oxygenation in Infants With Very Low Birth Weight: A Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2340597. doi: 10.1001/jamanetworkopen.2023.40597.'}, {'pmid': '40251781', 'type': 'DERIVED', 'citation': 'Kuehne B, Hellmich M, Heine E, Kribs A, Mehler K, Oberthuer A. Neurodevelopmental Outcomes of Very Low Birth Weight Infants Following Extrauterine Placental Perfusion: A Follow-Up Study. Acta Paediatr. 2025 Sep;114(9):2246-2252. doi: 10.1111/apa.70101. Epub 2025 Apr 18.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the effect of extrauterine placental transfusion (EPT) compared to delayed cord clamping (DCC) on the mean hematokrit on the first day of life in very low birth weight infants (VLBW) born by caesarian section. The investigators hypothesize that EPT provides higher blood volume during neonatal transition and improves neonatal outcome of VLBW infants.', 'detailedDescription': 'This prospective randomized controlled study will be conducted among 2 groups, all of them are preterm infants with birth weight less than 1500 g ("very low birth weight" (VLBW)) who are delivered by caesarean section, in the first interventional group an extrauterine placental transfusion (EPT) will be done during neonatal resuscitation with respiratory pressure support. There will be a delayed cord clamping (DCC) of at least 30 - 60 seconds in the control group, before starting neonatal resuscitation with respiratory support.\n\nIn EPT approach preterm born infants are delivered by caesarean section with the placenta still attached to the infant via the umbilical cord. Then, placental transfusion is performed up to several minutes by holding the placenta \\~40-50cm above the babies\' heart level while respiratory support by mask continuous-positive-airway-pressure (CPAP) is initiated simultaneously.\n\nExtrauterine placental transfusion may give more blood in babies delivered by cesarean section and may improve perfusion during the fetal-to-neonatal transition with impact on neonatal outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '24 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Birth weight \\< 1500 gram ("very low birth weight infant")\n* Delivery by caesarean section\n* Gestational age \\> 23+6 weeks\n\nExclusion Criteria:\n\n* Vaginal delivery\n* Fetal or maternal risk (i.e. compromise, emergency c-section)\n* Congenital anomalies and/or major cardiac defects\n* Placental abruption or previa with hemorrhage\n* Placenta accreta or increta\n* Monochorionic multiples (i.e. Di/Mo or Mo/Mo twins)\n* Parents declined study'}, 'identificationModule': {'nctId': 'NCT03916159', 'acronym': 'EXPLAIN', 'briefTitle': 'Extrauterine Placental Transfusion In Neonatal Resuscitation Of Very Low Birth Weight Infants', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Köln'}, 'officialTitle': 'Extrauterine Placental Transfusion In Neonatal Resuscitation (EXPLAIN) of Very Low Birth Weight Infants (VLBW): A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '18-232'}, 'secondaryIdInfos': [{'id': 'DRKS00017041', 'type': 'REGISTRY', 'domain': 'German Clinical Trials Register'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extrauterine Placental Transfusion EPT', 'description': 'Intervention group', 'interventionNames': ['Procedure: Extrauterine placental transfusion (Intervention group)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed cord clamping DCC', 'description': 'Control group', 'interventionNames': ['Procedure: Delayed cord clamping (Control group)']}], 'interventions': [{'name': 'Extrauterine placental transfusion (Intervention group)', 'type': 'PROCEDURE', 'description': "At delivery by caesarean section, the infant is born with the placenta still attached via the umbilical cord and placental transfusion is performed at least 1 minute but not more than 10 minutes by holding the placenta \\~40-50cm above the babies' heart level while respiratory support by mask continuous-positive-airway-pressure (CPAP) is initiated simultaneously.", 'armGroupLabels': ['Extrauterine Placental Transfusion EPT']}, {'name': 'Delayed cord clamping (Control group)', 'type': 'PROCEDURE', 'description': 'At delivery by caesarean section, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 30 seconds with initiation of respiratory support by mask CPAP after cord clamping.', 'armGroupLabels': ['Delayed cord clamping DCC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cologne', 'country': 'Germany', 'facility': 'University Hospital of Cologne, Department of pediatrics', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'André Oberthuer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital of Cologne, Department of Pediatrics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Köln', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andre Oberthür', 'investigatorAffiliation': 'Universitätsklinikum Köln'}}}}