protocolSection identificationModule nctId: NCT06265363, orgStudyIdInfo id: Turkey BigROP Study, briefTitle: Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants With a BW >1500 Grs or GA ≥33 Wks in Turkey., acronym: TR-BigROP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Baskent University Ankara Hospital, class: OTHER, collaborators name: Hacettepe University, collaborators name: Gazi University, collaborators name: Gaziosmanpasa Research and Education Hospital, collaborators name: Celal Bayar University, collaborators name: Selcuk University, collaborators name: Recep Tayyip Erdogan University, collaborators name: Karadeniz Technical University, collaborators name: Istinye University, collaborators name: Biruni University, collaborators name: T.C. ORDU ÜNİVERSİTESİ, collaborators name: Dr. Lutfi Kirdar Kartal Training and Research Hospital, collaborators name: Pamukkale University, collaborators name: Kanuni Sultan Suleyman Training and Research Hospital, collaborators name: Konya City Hospital, collaborators name: Kecioren Education and Training Hospital, collaborators name: Ataturk University, collaborators name: Meda Hospital, collaborators name: Eskisehir Osmangazi University, collaborators name: Necmettin Erbakan University, collaborators name: Kırıkkale University, collaborators name: Sisli Hamidiye Etfal Training and Research Hospital, collaborators name: Acibadem Atakent University Hospital, collaborators name: Balikesir Ataturk City Hospital, collaborators name: Kocaeli University, collaborators name: Acibadem Maslak Hospital, collaborators name: Erzurum City Hospital, collaborators name: Afyon Karahisar Hospital, collaborators name: Ankara Koru Hospital, collaborators name: University of Health Sciences Gulhane Hospital, collaborators name: Bursa Yüksek İhtisas Education and Research Hospital, collaborators name: Namik Kemal University, collaborators name: Bursa City Hospital, collaborators name: Kayseri City Hospital, collaborators name: Ankara Etlik City Hospital, collaborators name: Zonguldak Bulent Ecevit University, collaborators name: Gazi Yasargil Training and Research Hospital, collaborators name: Inonu University, collaborators name: Dr. Behcet Uz Children's Hospital, collaborators name: Ankara Training and Research Hospital, collaborators name: Tepecik Training and Research Hospital, collaborators name: Aydin Adnan Menderes University, collaborators name: Dicle University, collaborators name: Akdeniz University, collaborators name: Umraniye Education and Research Hospital, collaborators name: Ankara Bilkent City Hospital, collaborators name: Afyonkarahisar University of Health Sciences Health Application and Research Center, collaborators name: Harran University, collaborators name: Sanliurfa Mehmet Akif Inan Education and Research Hospital, collaborators name: Istanbul University - Cerrahpasa (IUC), collaborators name: Uludag University, collaborators name: şanlıurfa training and research Hospital, collaborators name: Dokuz Eylul University, collaborators name: Bursa Doruk Yıldırım Hospital, collaborators name: Malatya Turgut Ozal University, collaborators name: Abant Izzet Baysal University, collaborators name: Alanya Training and Research Hospital, collaborators name: İstanbul Training and Research Hospital, collaborators name: Baskent Univeristy Adana Hospital, collaborators name: Kahramanmaras Sutcu Imam University, collaborators name: Batman Training and Research Hospital, collaborators name: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital, collaborators name: Acıbadem Atunizade Hospital, collaborators name: Adiyaman Training and Research Hospital, collaborators name: Zeynep Kamil Maternity and Pediatric Research and Training Hospital, collaborators name: Ondokuz Mayıs University, collaborators name: Trakya University, collaborators name: Trabzon Kanuni Education and Research Hospital, collaborators name: Seyhan Hospital, collaborators name: Esenyurt University Hospital, collaborators name: Başakşehir Çam & Sakura City Hospital, collaborators name: Sakarya University, collaborators name: Mardin Training and Research Hospital, collaborators name: Karabuk University, collaborators name: Giresun Training and Research Hospital, collaborators name: Koc University Hospital, collaborators name: Tekirdağ City Hospital, collaborators name: Medipol University Mega Hospital, collaborators name: Adana City Training and Research Hospital, collaborators name: Istanbul University, collaborators name: Marmara University Pendik Training and Research Hospital, collaborators name: Medikal Park Ankara Hospital, collaborators name: Medipol University Bahcelievler Hospital, collaborators name: Muğla Sıtkı Koçman University, collaborators name: Yuzuncu Yıl University, collaborators name: Sanko University, collaborators name: Antalya Training and Research Hospital, collaborators name: Firat University, collaborators name: Ankara Güven Hospital, collaborators name: Private Batman Hospital, collaborators name: İstanbul Bağcılar Training and Research Hospital, collaborators name: Istanbul Aydın University, collaborators name: Mersin City Hospital, descriptionModule briefSummary: The study includes preterm infants who are being screened for ROP between August 1,2023 and August 1, 2024 in 94 neonatal intensive care units (NICUs) in Turkey. Infants with birth weight (BW) of \>1500 g or ≥ 33 weeks' gestation who are screened for retinopathy of prematurity are included. The incidence of any ROP, severe ROP and treatment modalities will be determined. The risk factors for ROP development will also be evaluated., conditionsModule conditions: Retinopathy of Prematurity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidence of ROP, secondaryOutcomes measure: The role of being SGA in infants in the development of ROP, secondaryOutcomes measure: The role of sepsis in infants in the development of ROP, secondaryOutcomes measure: The role of mechanical ventilation in infants in the development of ROP, secondaryOutcomes measure: The role of chorioamnionitis in infants in the development of ROP, secondaryOutcomes measure: Laser photocoagulation treatment, secondaryOutcomes measure: Anti-VEGF treatment, secondaryOutcomes measure: Vitreoretinal surgery, eligibilityModule sex: ALL, minimumAge: 28 Days, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Baskent University, status: RECRUITING, city: Ankara, country: Turkey, contacts name: Sezin Unal, role: CONTACT, phone: 0090532, email: sezinunal@gmail.com, contacts name: Esin Koc, Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Ahmet Y Bas, Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: İbrahim M Hirfanoğlu, Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False