Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 10:33 PM
Study NCT ID:
NCT07312669
Status:
COMPLETED
Last Update Posted:
2025-12-31
First Post:
2025-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ROP Check Database Premature Infant Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012178', 'term': 'Retinopathy of Prematurity'}, {'id': 'D001724', 'term': 'Birth Weight'}, {'id': 'D003075', 'term': 'Coitus'}], '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'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-12-16', 'size': 145123, 'label': 'Study Protocol and Statistical Analysis Plan: ROP Study protocol with Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-12-17T01:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7070}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-11-23', 'studyFirstSubmitQcDate': '2025-12-17', 'lastUpdatePostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ROP treatment: After examination, whether an infant reaching criteria for treatment and what treatment was given. Document the number and the proportion needing treatment.', 'timeFrame': '2010 through 2022', 'description': 'Type 1 ROP'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gestational age, birthweight, race, gender'], 'conditions': ['Retinopathy of Prematurity (ROP)']}, 'referencesModule': {'references': [{'pmid': '28850643', 'type': 'BACKGROUND', 'citation': 'Arnold RW, Jacob J, Matrix Z. Toward Achieving 100% Adherence for Retinopathy of Prematurity Screening Guidelines. J Pediatr Ophthalmol Strabismus. 2017 Nov 1;54(6):356-362. doi: 10.3928/01913913-20170329-04. Epub 2017 Aug 29.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observation of multi-centered care of infants covered by ROP Check cloud-based database is to compare demographic and clinical risk factors to evaluate and improve vision-protecting guidelines.', 'detailedDescription': 'Infants from multiple academic and community hospital neonatal intensive care units (NICUs) and their covering ophthalmologists had the serial eye examination and treatment data covered by ROP Check® cloud-based database. ROP Check assists neonatologists to implement guideline scheduling of infants according to the American Academy of Pediatrics (AAP). Outcome included progression to Type 1 retinopathy of prematurity (ROP) and treatment details such as intra-vitreal anti-VEGF injection and peripheral ablative laser. demographic data including birthweight, gestational age, gender, race/ethnicity are analyzed to determine risk factors severe ROP. Blindness-preventing guidelines are reviewed, analyzed and evidence-based updates are proposed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'NICU babies eligible for ROP examination', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NICU infants\n\nExclusion Criteria:\n\n* Term birth'}, 'identificationModule': {'nctId': 'NCT07312669', 'briefTitle': 'ROP Check Database Premature Infant Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Alaska Blind Child Discovery'}, 'officialTitle': 'ROP Check Premature Infant Outcomes', 'orgStudyIdInfo': {'id': 'ROPCHECK24'}}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': "Alaska Children's EYE & Strabismus", 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Interest level of other parties'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alaska Blind Child Discovery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}