Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-26 @ 12:37 AM
Study NCT ID:
NCT03607760
Status:
COMPLETED
Last Update Posted:
2019-04-10
First Post:
2018-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Extracorporeal Membrane Oxygenation (ECMO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-08', 'studyFirstSubmitDate': '2018-07-24', 'studyFirstSubmitQcDate': '2018-07-24', 'lastUpdatePostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'in-hospital mortality', 'timeFrame': "36 weeks' gestational age or before discharge from hospital", 'description': 'the patients died'}, {'measure': "28 days' mortality", 'timeFrame': '28 days', 'description': 'the patients died'}], 'secondaryOutcomes': [{'measure': 'Neonatal necrotizing enterocolitis', 'timeFrame': "36 weeks' gestational age or before discharge from hospital", 'description': 'Neonatal necrotizing enterocolitis was diagnosed after extubation'}, {'measure': 'Intraventricular hemorrhage', 'timeFrame': "36 weeks' gestational age or before discharge from hospital", 'description': 'Intraventricular hemorrhage was diagnosed after extubation'}, {'measure': 'bronchopulmonary dysplasia', 'timeFrame': "36 weeks' gestational age or before discharge from hospital", 'description': 'bronchopulmonary dysplasia was diagnosed after extubation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Extracorporeal Membrane Oxygenation']}, 'descriptionModule': {'briefSummary': 'Since the 1970s, extracorporeal membrane oxygenation (ECMO) support has been used to support gas exchange for children with severe acute respiratory failure who fail mechanical ventilation. ECMO is more expensive than each of these other procedures.But its action is unclear', 'detailedDescription': 'Since 1974, eight randomized controlled trials have been reported in ECMO for respiratory failure, and none have included non-neonatal pediatric patients. Cochrane systematic reviews of this evidence concluded that ECMO for neonatal respiratory failure had a survival advantage, but there was insufficient evidence to demonstrate a survival advantage for ECMO used to support respiratory failure in adults. Moreover, these trials were performed prior to 2009, and since then advances in ECMO technology have enhanced the delivery of ECMO support, and new research has changed conventional management of severe acute respiratory distress syndrome (ARDS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'minimumAge': '1 Hour', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the patients will be eligible only when they reach the cutting line in the following:\n\nGestational age \\> 36 weeks, birth weight \\> 2 kg, day post-birth \\< 28 days.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. ECMO group:\n\n1. Oxygenation Index \\> 40 for \\>4 hours\n2. Failure to wean from 100% oxygen despite prolonged (\\> 48h) maximal medical therapy or persistent episodes of decompensation\n3. Severe hypoxic respiratory failure with acute decompensation (PaO2 \\<40) unresponsive to intervention\n4. Severe pulmonary hypertension with evidence of right ventricular dysfunction and/or left ventricular dysfunction. The pulmonary artery pressure \\> 60mmHg evaluated by the Echo, arterial duct keeps open and the blood flow was either by-level shunt or completely shunt from right side to left side.\n\n2\\. Non-ECMO group:\n\n1. Oxygenation Index \\> 16 and reach the Montreux definition of severe respiratory distress syndrome\n2. Vasoactive-inotropic score (VIS) ≥ 40 \\[VIS=dopamine dose (μg/kg/min)×1 + dobutamine dose (μg/kg/min)×1 + milrinone dose (μg/kg/min)×10 + amrinone dose (μg/kg/min)×10 + epinephrine dose (μg/kg/min)×100 + isoprenaline dose (μg/kg/min)×100\\]\n\nExclusion Criteria:\n\n1. Gestational age \\< 36 weeks, birth weight \\< 2 kg, day post-birth \\> 28 days.\n2. lethal chromosomal disorder (includes trisomy 13, 18 but not 21) or any other lethal anomaly\n3. irreversible brain damage\n4. uncontrolled bleeding\n5. Grade III or greater intraventricular hemorrhage\n6. ventilator days ≥ 15 days.'}, 'identificationModule': {'nctId': 'NCT03607760', 'briefTitle': 'Extracorporeal Membrane Oxygenation (ECMO)', 'organization': {'class': 'OTHER', 'fullName': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}, 'officialTitle': 'Extracorporeal Membrane Oxygenation (ECMO) and Neonatal Outcomes:a Retrospective Multicenters Study', 'orgStudyIdInfo': {'id': 'ECMO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ECMO', 'description': 'severe respiratory failure with ECMO', 'interventionNames': ['Device: ECMO']}, {'label': 'conventional mechanical ventilation', 'description': 'severe respiratory failure with conventional mechanical ventilation', 'interventionNames': ['Device: conventional mechanical ventilation']}], 'interventions': [{'name': 'ECMO', 'type': 'DEVICE', 'description': 'the patients with severe respiratory failure were supported by ECMO', 'armGroupLabels': ['ECMO']}, {'name': 'conventional mechanical ventilation', 'type': 'DEVICE', 'description': 'the patients with severe respiratory failure were supported by conventional mechanical ventilation', 'armGroupLabels': ['conventional mechanical ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': "Bayi Children's Hospital Affiliated to PLA Army General Hospital, China", 'class': 'OTHER'}, {'name': "Children's Hospital of Chongqing Medical University", 'class': 'OTHER'}, {'name': "Hunan Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, {'name': 'Beijing 302 Hospital', 'class': 'OTHER'}, {'name': 'Navy General Hospital, Beijing', 'class': 'OTHER'}, {'name': "Zhengzhou Children's Hospital, China", 'class': 'OTHER'}, {'name': "Guangzhou Women and Children's Medical Center", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Chen Long,MD', 'investigatorAffiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}}}}