Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 8:07 AM
Study NCT ID:
NCT01363960
Status:
COMPLETED
Last Update Posted:
2011-06-02
First Post:
2011-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinopathy of Prematurity:Summary of a Decade
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012178', 'term': 'Retinopathy of Prematurity'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 609}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-31', 'studyFirstSubmitDate': '2011-05-27', 'studyFirstSubmitQcDate': '2011-05-31', 'lastUpdatePostDateStruct': {'date': '2011-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of neonates developed retinopathy of prematurity', 'timeFrame': 'ten years'}, {'measure': 'risk factors contributing to ROP development', 'timeFrame': 'ten years', 'description': 'mechanic ventilation. oxygen therapy, respiratory distress syndrome, sepsis, intraventricular, hemorrhage, blood transfusion v.s'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Incidence', 'neonatal care', 'retinopathy of prematurity', 'risk factors'], 'conditions': ['Retinopathy of Prematurity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'retinopathy of prematurity'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate our 10 year experience of retinopathy of prematurity screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'neonates with Retinopathy of of prematurity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neonates either with a BW of less than 1501 gram (g) or born at a GA of 34 weeks (wk) or less\n* selected infants with an unstable clinical course were included'}, 'identificationModule': {'nctId': 'NCT01363960', 'briefTitle': 'Retinopathy of Prematurity:Summary of a Decade', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi'}, 'orgStudyIdInfo': {'id': 'Retinopathy of prematurity'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'neonates with retinopathy of prematurity', 'description': 'all neonates meet the criteria:\n\n1. a BW of less than 1501 gram (g)\n2. born at a GA of 34 weeks (wk) or less and\n3. selected infants with an unstable clinical course were included'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06010', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gulhane Military Medical School Training Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Murat KÜÇÜKEVCİLİOĞLU, MD', 'oldOrganization': 'Gulhane Military Medical School'}}}}