Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-04 @ 7:57 AM
Study NCT ID:
NCT03296059
Status:
UNKNOWN
Last Update Posted:
2022-10-25
First Post:
2017-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-23', 'studyFirstSubmitDate': '2017-09-25', 'studyFirstSubmitQcDate': '2017-09-27', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'death rate', 'timeFrame': 'within 100 days', 'description': 'neonate died due to respiratory failure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Red Blood Cells(RBC)', 'Acute Respiratory Distress Syndrome (ARDS)']}, 'referencesModule': {'references': [{'pmid': '38780066', 'type': 'DERIVED', 'citation': 'Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.\n\nThe death rate is over 50%.There are no special treatments for acute respiratory distress syndrome.', 'detailedDescription': 'Acute respiratory distress syndrome (ARDS) is one of the serious complications in critically ill neonates. It can result in severe hypoxemia refractory to mechanical ventilation. There are few options for mechanical ventilation for such situations such as high frequency oscillation ventilation and extracorporeal membrane oxygenation. The aim of the present study is to determine whether transfusion of red blood cells can decrease the mortality in neonate with ARDS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'minimumAge': '30 Minutes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with neonatal ARDS.\n* informed parental consent has been obtained\n\nExclusion Criteria:\n\n* major congenital malformations or complex congenital heart disease\n* transferred out of the neonatal intensive care unit without treatment'}, 'identificationModule': {'nctId': 'NCT03296059', 'briefTitle': 'Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}, 'officialTitle': 'Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '201732'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RBC transfusion with conventional treatment', 'description': 'Besides conventional treatment,neonates diagnosed with ARDS is treated with RBC transfusion.', 'interventionNames': ['Other: conventional treatment with RBC transfusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional treatment', 'description': 'neonates diagnosed with ARDS is treated with conventional treatment.', 'interventionNames': ['Other: conventional treatment']}], 'interventions': [{'name': 'conventional treatment with RBC transfusion', 'type': 'OTHER', 'description': 'Besides conventional treatment, neonates is given RBC transfusion.', 'armGroupLabels': ['RBC transfusion with conventional treatment']}, {'name': 'conventional treatment', 'type': 'OTHER', 'description': 'neonates is treated with conventional treatment.', 'armGroupLabels': ['conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shi Yuan, PhD,MD', 'role': 'CONTACT'}], 'facility': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Ma Juan, MD', 'role': 'CONTACT', 'email': '476679422@qq.com', 'phone': '13508300283'}, {'name': 'Ma Juan, MD', 'role': 'CONTACT', 'email': '476679422@qq.com', 'phone': '1388559467'}], 'overallOfficials': [{'name': 'Shi Yuan, PhD,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director', 'investigatorFullName': 'Ma Juan', 'investigatorAffiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}}}}