Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT00196469
Status:
UNKNOWN
Last Update Posted:
2007-10-23
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Heparin on the Need for Mechanical Ventilation in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2007-03'}, 'lastUpdateSubmitDate': '2007-10-22', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2007-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of neonates requiring mechanical ventilation'}], 'secondaryOutcomes': [{'measure': 'duration of dependency on mechanical ventilation'}, {'measure': 'major bleeding'}, {'measure': 'heparin induced thrombocytopenia'}, {'measure': 'anti PF4/heparin antibodies'}]}, 'conditionsModule': {'conditions': ['Respiration, Artificial', 'Hemorrhage']}, 'descriptionModule': {'briefSummary': 'This study is designed to test an incidental finding of a previous trial in which post hoc analysis showed that the rate of intensive care newborns requiring mechanical ventilation was lower in the group receiving heparin with the continuous infusion as compared to the placebo group.', 'detailedDescription': 'Title: Randomized double blind trial comparing heparin and placebo as additives to continuous infusion in intensive care neonates for prevention of mechanical ventilation\n\nPrimary endpoint: Percentage of neonates requiring mechanical ventilation in both groups\n\nSecondary endpoints: Duration of dependency on mechanical ventilation; major bleedings, incidence of heparin-induced thrombocytopenia and of anti-platelet factor 4/heparin antibodies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborns \\< day 28 of life\n* Necessity for intensive care treatment\n* Necessity for parenteral drug or fluid application for at least five days\n* Informed consent of parents\n\nExclusion Criteria:\n\n* Body weight \\< 500g\n* Mechanical ventilation directly after birth\n* Major malformations\n* Absolute indication for heparin\n* Inborn hemorrhagic disease (e.g. hemophilia, von Willebrand disease)\n* Cerebral bleeding or other major bleeding\n* Platelet count \\< 50,000/µl'}, 'identificationModule': {'nctId': 'NCT00196469', 'briefTitle': 'Impact of Heparin on the Need for Mechanical Ventilation in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'Randomized Double Blind Trial Comparing Heparin and Placebo as Additives to Continuous Infusion in Intensive Care Neonates for Prevention of Ventilation', 'orgStudyIdInfo': {'id': 'EMAU16253.00.00'}}, 'armsInterventionsModule': {'interventions': [{'name': 'heparin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17487', 'city': 'Greifswald', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andreas Greinacher, MD', 'role': 'CONTACT', 'email': 'greinach@uni-greifswald.de', 'phone': '+49 3834-865482'}, {'name': 'Christoph Fusch, MD', 'role': 'CONTACT', 'email': 'fusch@uni-greifswald.de', 'phone': '+49-3834-866420'}, {'name': 'Andreas Greinacher, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christoph Fusch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anne F Klenner, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Department of Pediatrics/Institute for Immunology and Transfusion Medicine', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}], 'centralContacts': [{'name': 'Andreas Greinacher, MD', 'role': 'CONTACT', 'email': 'greinach@uni-greifswald.de'}], 'overallOfficials': [{'name': 'Andreas Greinacher, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute for Immunology and Transfusion Medicine, Ernst-Moritz-Arndt-University Greifswald'}, {'name': 'Christoph Fusch, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pediatric Department, Ernst-Moritz-Arndt-University Greifswald'}, {'name': 'Anne F Klenner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Faculty, Ernst-Moritz-Arndt University Greifswald'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}}}}