Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-01 @ 12:39 AM
Study NCT ID:
NCT06729333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-11
First Post:
2024-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter and Prospective Study of Screening Retinopathy of Prematurity in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D012178', 'term': 'Retinopathy of Prematurity'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'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', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-06-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2024-12-04', 'studyFirstSubmitQcDate': '2024-12-06', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence rate of ROP', 'timeFrame': '6 months after the first screening'}, {'measure': 'Gestational age at which treatment-requiring ROP develops', 'timeFrame': '6 months after the first screening'}, {'measure': 'Birthweight at which treatment-requiring ROP develops', 'timeFrame': '6 months after the first screening'}], 'secondaryOutcomes': [{'measure': 'Gestational age of infants developing any ROP lesion', 'timeFrame': '6 months after the first screening'}, {'measure': 'Birthweight of infants developing any ROP lesion', 'timeFrame': '6 months after the first screening'}, {'measure': 'Postmenstrual age (PMA) at which ROP lesions occur', 'timeFrame': '6 months after the first screening'}, {'measure': 'PMA at which treatment-requiring ROP occurs', 'timeFrame': '6 months after the first screening'}, {'measure': 'Screening and treatment costs', 'timeFrame': '6 months after the first screening'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['retinopathy of prematurity', 'incidence rate', 'screening'], 'conditions': ['Premature Birth of Newborn', 'Retinopathy of Prematurity (ROP)', 'Low Birthweight Infant']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to explore the current incidence rate of retinopathy of prematurity (ROP) in China and to explore more appropriate screening criteria for ROP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Tertiary hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFrom December 2024 to May 2025, preterm infants (gestational age \\<37 weeks) or low birth weight infants (birth weight \\<2500 g) who receive their first ROP screening at Xinhua Hospital or partner institutions will be included.\n\nExclusion Criteria:\n\n1. Death before the first screening;\n2. Death or loss to follow-up before complete retinal vascularization;\n3. Presence of other diseases causing incomplete retinal vascularization, such as familial exudative vitreoretinopathy, incontinentia pigmenti, or Coats disease;\n4. Coexisting conditions affecting the classification or staging of ROP, such as corneal opacity, congenital cataract, persistent fetal vasculature, retinoblastoma, anophthalmia, Terson syndrome, or other ocular infections or diseases;\n5. Poor systemic condition preventing fundus examination;\n6. History of ocular trauma or surgery (excluding treatments for ROP);\n7. Poor-quality fundus images;\n8. Other conditions deemed exclusionary by the investigators.'}, 'identificationModule': {'nctId': 'NCT06729333', 'acronym': 'SChiROP', 'briefTitle': 'A Multicenter and Prospective Study of Screening Retinopathy of Prematurity in China', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'A Multicenter and Prospective Study of Screening Retinopathy of Prematurity in China', 'orgStudyIdInfo': {'id': 'XHEC-C-2024-205-1'}}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Ping Fei, MD', 'role': 'CONTACT', 'email': 'shirleypingfei@126.com', 'phone': '86+15000672472'}, {'name': 'Peiquan Zhao, PhD', 'role': 'CONTACT'}], 'facility': 'Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ping Fei, MD', 'role': 'CONTACT', 'email': 'shirleypingfei@126.com', 'phone': '86+15000672472'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Department of Ophthalmology', 'investigatorFullName': 'Peiquan Zhao', 'investigatorAffiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}}}}