Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT01652118
Status:
UNKNOWN
Last Update Posted:
2012-07-27
First Post:
2012-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clarithromycin Prophylaxis in Preterm Infants Colonisation With Ureaplasma Urealyticum and Mycoplasma Hominis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-26', 'studyFirstSubmitDate': '2012-07-22', 'studyFirstSubmitQcDate': '2012-07-26', 'lastUpdatePostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bronchopulmonary dysplasia', 'timeFrame': '28. day of birth', 'description': 'On the 28. day of birth, The investigator will determine the baby whether has developed bronchopulmonary dysplasia'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of postnatal 40 weeks', 'description': 'During to hospitalisation the investigator will determine and record some co-morbidities of BPD such as intracranial hemorrhage, necrotizing enterocolitis, patent ductus arteriosus rates.From date of randomization until the end of the hospitalisation up to the 3 months of life.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bronchopulmonary dysplasia', 'clarithromycin', 'preterm babies'], 'conditions': ['Bronchopulmonary Dysplasia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine of clarithromycin effect on developing of bronchopulmonary dysplasia in preterm babies.', 'detailedDescription': 'The investigators planned that clarithromycin treatment in preterm babies who are under 1250 grams birth weight.\n\nThe investigators aimed with this treatment, the bronchopulmonary dysplasia rate of preterm babies may decrease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Days', 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all infant must be under 1250 gram birth weight\n\nExclusion Criteria:\n\n* Major congenital anomaly,\n* CardiaC abnormality,\n* without inform consent'}, 'identificationModule': {'nctId': 'NCT01652118', 'acronym': 'Claprum', 'briefTitle': 'Clarithromycin Prophylaxis in Preterm Infants Colonisation With Ureaplasma Urealyticum and Mycoplasma Hominis', 'organization': {'class': 'OTHER', 'fullName': "Zekai Tahir Burak Women's Health Research and Education Hospital"}, 'officialTitle': 'Prophylaxis of Bronchopulmonary Dysplasia With Clarithromycin', 'orgStudyIdInfo': {'id': '05059079727'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Clarithromycin', 'description': 'Fist group treated with clarithromycin which is include 10 days application.', 'interventionNames': ['Drug: clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Second group treated with salin as same as amount of clarithromycine volume', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia', 'type': 'DRUG', 'otherNames': ['Claprum'], 'armGroupLabels': ['Clarithromycin']}, {'name': 'Saline', 'type': 'DRUG', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06600', 'city': 'Ankara', 'state': 'Middle Anatolia', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sadık Yurttutan, M.D', 'role': 'CONTACT', 'phone': '0905059079727'}, {'name': 'Fuat Emre Canpolat, M.D.', 'role': 'CONTACT', 'email': 'femrecan@gmail.com'}, {'name': 'Sadık Yurttutan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zekai Tahir Burak Maternity Teaching Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Sadık Yurttutan, M.D', 'role': 'CONTACT', 'email': 'sdkyurttutan@gmail.com', 'phone': '0905059079727'}, {'name': 'Fuat Emre Canpolat, M.D.', 'role': 'CONTACT', 'email': 'femrecan@gmail.com'}], 'overallOfficials': [{'name': 'Ugur Dilmen, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': "Zekai Tahir Burak Women's Health Research and Education Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zekai Tahir Burak Women's Health Research and Education Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellowship of neonatology', 'investigatorFullName': 'Sadik Yurttutan', 'investigatorAffiliation': "Zekai Tahir Burak Women's Health Research and Education Hospital"}}}}