Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT01178905
Status:
COMPLETED
Last Update Posted:
2013-04-24
First Post:
2010-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Ultrashort-term Heat Inactivation of Cytomegalovirus (CMV) Containing Raw Breast Milk to Prevent CMV-infection of Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'lastUpdateSubmitDate': '2013-04-23', 'studyFirstSubmitDate': '2010-07-26', 'studyFirstSubmitQcDate': '2010-08-09', 'lastUpdatePostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with CMV viruria', 'timeFrame': '40 weeks gestational age, or at discharge from NICU (if this is earlier)'}], 'secondaryOutcomes': [{'measure': 'Number of participants with specific neonatal outcome parameters as a measure of neonatal quality', 'timeFrame': '40 weeks of gestational age or at discharge from NICU (if this is earlier)', 'description': 'Intracranial hemorrhage (ICH) Periventricular leucomalacia (PVL) Necrotizing enterocolitis (NEC) Bronchopulmonary dysplasia (BPD) Retinopathy of prematurity (ROP)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Postnatal CMV infection of preterm infants', 'breast milk'], 'conditions': ['Cytomegalovirus Infection', 'Preterm Infants']}, 'referencesModule': {'references': [{'pmid': '30407512', 'type': 'DERIVED', 'citation': 'Bapistella S, Hamprecht K, Thomas W, Speer CP, Dietz K, Maschmann J, Poets CF, Goelz R. Short-term Pasteurization of Breast Milk to Prevent Postnatal Cytomegalovirus Transmission in Very Preterm Infants. Clin Infect Dis. 2019 Jul 18;69(3):438-444. doi: 10.1093/cid/ciy945.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate, in a prospective multicenter study, ultrashort-term heat inactivation for the prevention of Cytomegalovirus (CMV) transmission in preterm infants (\\<32 weeks gestational age or \\<1500 g birth weight) under clinical conditions. Inactivation will be done only during the period of infectivity of breast milk, characterized by viral excretion strongly associated with subsequent infection, monitored by periodic virologic examinations of BM and urine of the infant. Thus the investigators hypothesis is that no CMV transmission through breast milk will occur using a gentle ultrashort heat inactivation procedure applied to infective breast milk.\n\nThe protocol has been approved by the ethics committee of Tuebingen University Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '40 Weeks', 'minimumAge': '23 Weeks', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\<32 Weeks or GA or \\<1500g BW\n* mother CMV IgG positive\n* breast milk feeding\n\nExclusion Criteria:\n\n* parents disagree'}, 'identificationModule': {'nctId': 'NCT01178905', 'briefTitle': 'Clinical Evaluation of Ultrashort-term Heat Inactivation of Cytomegalovirus (CMV) Containing Raw Breast Milk to Prevent CMV-infection of Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Clinical Evaluation of a Gentle But Safe Ultrashort-term Heat Inactivation Procedure of Raw Breast Milk (BM) Containing Virulent Cytomegalovirus for Preventing CMV-infection of Preterm Infants', 'orgStudyIdInfo': {'id': 'BM CMV inactivation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Mother CMV positive', 'interventionNames': ['Procedure: ultrashort heat inactivation']}], 'interventions': [{'name': 'ultrashort heat inactivation', 'type': 'PROCEDURE', 'armGroupLabels': ['Mother CMV positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72070', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Tuebingen University Hospital', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Rangamr Goelz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tuebingen University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}}}}