Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-03 @ 4:12 PM
Study NCT ID:
NCT03314233
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2017-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Delayed Cord Clamping for Congenital Diaphragmatic Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065630', 'term': 'Hernias, Diaphragmatic, Congenital'}], 'ancestors': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006548', 'term': 'Hernia, Diaphragmatic'}, {'id': 'D000082122', 'term': 'Internal Hernia'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'foglia@email.chop.edu', 'phone': '215-590-1653', 'title': 'Dr. Elizabeth Foglia', 'organization': 'Childrens Hospital of Philadelphia'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '24 hours following allocation to the DING intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'DING Intervention', 'description': 'Delayed Cord Clamping\n\nDING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children\'s Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Infants Who Are Intubated Prior to Umbilical Cord Clamping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DING Intervention', 'description': 'Delayed Cord Clamping\n\nDING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children\'s Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 minutes of life', 'description': 'Infants who are intubated and have ventilation initiated prior to umbilical cord clamping', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Arterial Potential of Hydrogen (pH) in Arterial Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DING Intervention', 'description': 'Delayed Cord Clamping\n\nDING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children\'s Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.02', 'spread': '0.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 1 hour of life', 'description': 'Arterial pH on first blood gas', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results.'}, {'type': 'SECONDARY', 'title': 'Mean Partial Pressure of O2 in Arterial Blood (PaO2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DING Intervention', 'description': 'Delayed Cord Clamping\n\nDING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children\'s Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '39', 'upperLimit': '52'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Approximately 1 hour of life', 'description': 'Arterial PaO2 on first blood gas', 'unitOfMeasure': 'PaO2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results.'}, {'type': 'SECONDARY', 'title': 'Oxygenation Index (OI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DING Intervention', 'description': 'Delayed Cord Clamping\n\nDING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children\'s Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '25.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'First obtained blood gas', 'description': 'Oxygenation index \\[OI\\] with first obtained blood gas', 'unitOfMeasure': 'oxygenation index', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results.'}, {'type': 'SECONDARY', 'title': 'Proportion of Infants Who Require Vasopressors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DING Intervention', 'description': 'Delayed Cord Clamping\n\nDING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children\'s Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First 48 hours of life', 'description': 'Proportion of infants who require vasopressors in first 48 hours of life', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results.'}, {'type': 'SECONDARY', 'title': 'Presence of Severe Pulmonary Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DING Intervention', 'description': 'Delayed Cord Clamping\n\nDING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children\'s Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 24 hours of life', 'description': 'Presence of severe pulmonary hypertension on first echocardiogram', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results. 1 trial participant was supported with ECMO when the echocardiogram was obtained and therefore was not assessed.'}, {'type': 'SECONDARY', 'title': 'Proportion of Infants Who Require Extracorporeal Membrane Oxygenation (ECMO) Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DING Intervention', 'description': 'Delayed Cord Clamping\n\nDING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children\'s Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days of life', 'description': 'Proportion of infants who require ECMO treatment in first 7 days of life', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results.'}, {'type': 'SECONDARY', 'title': 'Mortality in First 7 Days of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DING Intervention', 'description': 'Delayed Cord Clamping\n\nDING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children\'s Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First 7 days of life', 'description': 'Proportion of infants with mortality in the first 7 days of life', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DING Intervention', 'description': 'Delayed Cord Clamping\n\nDING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children\'s Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '21 mothers provided informed consent for participation in the trial.', 'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '20 mothers who had provided informed consent met eligibility criteria at time of delivery.', 'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'No longer eligible at time of delivery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'DING Intervention', 'description': 'Delayed Cord Clamping\n\nDING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children\'s Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Gestational Age', 'categories': [{'measurements': [{'value': '38.7', 'spread': '0.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-05', 'size': 568080, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-25T17:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Unblinded single-arm pilot interventional trial. All enrolled infants will receive the DING intervention (Delayed cord clamping for INtubation and Gentle ventilation)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-08', 'studyFirstSubmitDate': '2017-10-02', 'resultsFirstSubmitDate': '2019-11-01', 'studyFirstSubmitQcDate': '2017-10-17', 'lastUpdatePostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-22', 'studyFirstPostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Infants Who Are Intubated Prior to Umbilical Cord Clamping', 'timeFrame': '3 minutes of life', 'description': 'Infants who are intubated and have ventilation initiated prior to umbilical cord clamping'}], 'secondaryOutcomes': [{'measure': 'Mean Arterial Potential of Hydrogen (pH) in Arterial Blood', 'timeFrame': 'Approximately 1 hour of life', 'description': 'Arterial pH on first blood gas'}, {'measure': 'Mean Partial Pressure of O2 in Arterial Blood (PaO2)', 'timeFrame': 'Approximately 1 hour of life', 'description': 'Arterial PaO2 on first blood gas'}, {'measure': 'Oxygenation Index (OI)', 'timeFrame': 'First obtained blood gas', 'description': 'Oxygenation index \\[OI\\] with first obtained blood gas'}, {'measure': 'Proportion of Infants Who Require Vasopressors', 'timeFrame': 'First 48 hours of life', 'description': 'Proportion of infants who require vasopressors in first 48 hours of life'}, {'measure': 'Presence of Severe Pulmonary Hypertension', 'timeFrame': 'Approximately 24 hours of life', 'description': 'Presence of severe pulmonary hypertension on first echocardiogram'}, {'measure': 'Proportion of Infants Who Require Extracorporeal Membrane Oxygenation (ECMO) Treatment', 'timeFrame': '7 days of life', 'description': 'Proportion of infants who require ECMO treatment in first 7 days of life'}, {'measure': 'Mortality in First 7 Days of Life', 'timeFrame': 'First 7 days of life', 'description': 'Proportion of infants with mortality in the first 7 days of life'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Diaphragmatic Hernia']}, 'referencesModule': {'references': [{'pmid': '25825963', 'type': 'BACKGROUND', 'citation': "Grover TR, Murthy K, Brozanski B, Gien J, Rintoul N, Keene S, Najaf T, Chicoine L, Porta N, Zaniletti I, Pallotto EK; Children's Hospitals Neonatal Consortium. Short-term outcomes and medical and surgical interventions in infants with congenital diaphragmatic hernia. Am J Perinatol. 2015 Sep;32(11):1038-44. doi: 10.1055/s-0035-1548729. Epub 2015 Mar 31."}]}, 'descriptionModule': {'briefSummary': 'Congenital diaphragmatic hernia (CDH) is a congenital anomaly associated with a high risk of mortality and need for life-saving interventions such as extracorporeal membrane oxygenation (ECMO), nitric oxide, and vasopressor support. Although infants with CDH experience significant morbidity and mortality starting immediately after birth, high quality evidence informing delivery room resuscitation in this population is lacking.\n\nInfants with CDH are at risk for pulmonary hypoplasia and pulmonary hypertension and often experience hypoxemia and acidosis during neonatal transition. The standard approach to DR resuscitation is immediate umbilical cord clamping (UCC) followed by intubation and mechanical ventilation. Animal models suggest that achieving lung aeration prior to UCC results in improved pulmonary blood flow and cardiac function compared with immediate UCC before lung aeration is established. Trials of preterm infants demonstrated that initiating respiratory support prior to UCC is safe and feasible. Because infants with CDH are at high risk for pulmonary hypertension and systemic hypotension, they may benefit from the hemodynamic effects of lung aeration before UCC, namely increased pulmonary blood flow, decreased pulmonary vascular resistance, and improved cardiac output. To date, this approach has not been studied in infants with CDH.', 'detailedDescription': 'Congenital diaphragmatic hernia (CDH) is a congenital anomaly associated with a high risk of mortality (29%) and need for life-saving interventions such as ECMO (33%), nitric oxide (62%), and vasopressor support (73%).1 Although infants with CDH experience significant morbidity and mortality starting immediately after birth, high quality evidence informing delivery room resuscitation in this population is lacking.\n\nInfants with CDH are at risk for pulmonary hypoplasia and pulmonary hypertension and often experience hypoxemia and acidosis during neonatal transition. The standard approach to delivery room (DR) resuscitation is immediate UCC followed by intubation and mechanical ventilation. The goals of this strategy are to immediately recruit and aerate the lung for gas exchange and oxygenation, while simultaneously avoiding gaseous distention of the thoracic gastrointestinal contents.\n\nAnimal models suggest that achieving lung aeration prior to UCC results in improved pulmonary blood flow and cardiac function compared with immediate UCC before lung aeration is established. Trials of preterm infants demonstrated that initiating respiratory support prior to UCC is safe and feasible. Because infants with CDH are at high risk for pulmonary hypertension and systemic hypotension, they may benefit from the hemodynamic effects of lung aeration before UCC, namely increased pulmonary blood flow, decreased pulmonary vascular resistance, and improved cardiac output.\n\nThe investigators hypothesize that a sequence of intubation, gentle ventilation, and then umbilical cord clamping will result in improved cardiovascular transition after birth in infants with CDH. To date, this approach has not been studied in infants with CDH. The DING trial will assess the feasibility and safety of this intervention in infants with CDH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Antenatal diagnosis of CDH, with care in the Center for Fetal Treatment\n2. Gestational age ≥ 36 weeks at birth\n\nExclusion Criteria:\n\n1. Multiple gestation\n2. Major anomalies or aneuploidy\n3. Enrolled in fetal endoluminal tracheal occlusion (FETO) trial\n4. Palliative care planned or considered\n5. Maternal diagnosis placenta previa, accreta, or abruption\n6. Maternal diagnosis pre-eclampsia requiring Magnesium sulfate therapy at time of delivery\n7. Obstetrics (OB) or Neonatal provider concerns for the clinical care of the mother or infant, or study team not available'}, 'identificationModule': {'nctId': 'NCT03314233', 'acronym': 'DING', 'briefTitle': 'Delayed Cord Clamping for Congenital Diaphragmatic Hernia', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Delayed Cord Clamping for Intubation and Gentle Ventilation in Infants With Congenital Diaphragmatic Hernia', 'orgStudyIdInfo': {'id': '17-014125'}, 'secondaryIdInfos': [{'id': 'K23HD084727', 'link': 'https://reporter.nih.gov/quickSearch/K23HD084727', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DING intervention', 'description': 'Delayed Cord Clamping', 'interventionNames': ['Procedure: DING']}], 'interventions': [{'name': 'DING', 'type': 'PROCEDURE', 'description': 'Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children\'s Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.', 'armGroupLabels': ['DING intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Elizabeth Foglia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}