Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants with a BW >1500 Grs or GA ≥33 Wks in Turkey.
NCT ID: NCT06265363
Last Updated: 2024-11-01
Study Results
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Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2023-08-01
2024-12-01
Brief Summary
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Detailed Description
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An electronic questionnaire is being filled by certified neonatologists in Turkey via a special network. Neonatologists working in 94 centers who agreed to participate in this study provide their data regarding the ROP in their NICU. The medical records of retinal examinations of preterm infants who met the screening criteria will be evaluated.
A case report form for each patient will be filled including risk factors for the development of ROP such as gestational age, birth weight, small for gestational age (SGA), gender, multiple gestation, antenatal steroid therapy, invitro fertilization, preeclampsia/eclampsia, infants of diabetic mother, chorioamnionitis, resuscitation in delivery room, respiratory distress syndrome (RDS), duration of mechanical ventilation and oxygen therapy, intracranial hemorrhage, hemodynamically significant patent ductus arteriosus (PDA), early/late sepsis, necrotising enterocolitis (NEC), number of blood transfusions, bronchopulmonary dysplasia (BPD), time to full enteral feeding, percentage of own mothers milk.
Risk factors for developing ROP will be evaluated. Multivariate analysis will be performed among significant variables. In addition, the incidence of any ROP, severe ROP in relation to GA and BW and treatment modalities will be determined.
Severe ROP is defined as ROP requiring treatment. Since Turkey is receiving many refugees in recent years, the investigators also planned to evaluate the incidence and risk factors for developing ROP in preterm babies of refugees.
Ophthalmologic examination is continued until full vascularisation. So, the maximum stage of ROP detected for every infant will be reported. Data from 94 NICUs will be pooled together and analyzed.
The "International Classification of ROP" guidelines (ICROP-3) are used to record the stage of disease, location by zone, signs of plus disease and signs of regression/reactivation/persistent avascular retina.
Criteria for treatment of ROP are based on the Early Treatment for Retinopathy of Prematurity (ETROP) recommendation.
Confirmed forms are also assigned by the parents before the initial screening and treatment.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
28 Days
ALL
No
Sponsors
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Hacettepe University
OTHER
Gazi University
OTHER
Gaziosmanpasa Research and Education Hospital
OTHER_GOV
Celal Bayar University
OTHER
Selcuk University
OTHER
Recep Tayyip Erdogan University
OTHER
Karadeniz Technical University
OTHER
Istinye University
OTHER
Biruni University
OTHER
Ordu University
OTHER
Dr. Lutfi Kirdar Kartal Training and Research Hospital
OTHER_GOV
Pamukkale University
OTHER
Kanuni Sultan Suleyman Training and Research Hospital
OTHER
Konya City Hospital
OTHER
Kecioren Education and Training Hospital
OTHER
Ataturk University
OTHER
Meda Hospital
UNKNOWN
Eskisehir Osmangazi University
OTHER
Necmettin Erbakan University
OTHER
Kırıkkale University
OTHER
Sisli Hamidiye Etfal Training and Research Hospital
OTHER
Acibadem Atakent University Hospital
OTHER
Balikesir Ataturk City Hospital
OTHER_GOV
Kocaeli University
OTHER
Acibadem Maslak Hospital
OTHER
Erzurum City Hospital
OTHER
Afyon Karahisar Hospital
UNKNOWN
Ankara Koru Hospital
UNKNOWN
Gulhane School of Medicine
OTHER
Bursa Yuksek Ihtisas Training and Research Hospital
OTHER_GOV
Namik Kemal University
OTHER
Bursa City Hospital
OTHER_GOV
Kayseri City Hospital
OTHER_GOV
Ankara Etlik City Hospital
OTHER_GOV
Zonguldak Bulent Ecevit University
OTHER
Gazi Yasargil Training and Research Hospital
UNKNOWN
Inonu University
OTHER
Dr. Behcet Uz Children's Hospital
OTHER
Ankara Training and Research Hospital
OTHER
Tepecik Training and Research Hospital
OTHER
Aydin Adnan Menderes University
OTHER
Dicle University
OTHER
Akdeniz University
OTHER
Umraniye Education and Research Hospital
OTHER_GOV
Ankara City Hospital Bilkent
OTHER
Afyonkarahisar University of Health Sciences Health Application and Research Center
UNKNOWN
Harran University
OTHER
Sanliurfa Mehmet Akif Inan Education and Research Hospital
OTHER
Istanbul University - Cerrahpasa
OTHER
Uludag University
OTHER
şanlıurfa training and research Hospital
UNKNOWN
Dokuz Eylul University
OTHER
Bursa Doruk Yıldırım Hospital
UNKNOWN
Malatya Turgut Ozal University
OTHER
Abant Izzet Baysal University
OTHER
Alanya Training and Research Hospital
UNKNOWN
İstanbul Training and Research Hospital
UNKNOWN
Baskent University
OTHER
Kahramanmaras Sutcu Imam University
OTHER
Batman Training and Research Hospital
OTHER_GOV
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
OTHER
Acıbadem Atunizade Hospital
OTHER
Adiyaman Training and Research Hospital
UNKNOWN
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
OTHER
Ondokuz Mayıs University
OTHER
Trakya University
OTHER
Trabzon Kanuni Education and Research Hospital
OTHER
Seyhan Hospital
UNKNOWN
Esenyurt University Hospital
UNKNOWN
Başakşehir Çam & Sakura City Hospital
OTHER_GOV
Sakarya University
OTHER
Mardin Training and Research Hospital
UNKNOWN
Karabuk University
OTHER
Giresun Training and Research Hospital
UNKNOWN
Koc University Hospital
OTHER
Tekirdağ City Hospital
UNKNOWN
Medipol University Mega Hospital
UNKNOWN
Adana City Training and Research Hospital
OTHER
Istanbul University
OTHER
Marmara University Pendik Training and Research Hospital
OTHER
Medikal Park Ankara Hospital
UNKNOWN
Medipol University Bahcelievler Hospital
UNKNOWN
Muğla Sıtkı Koçman University
OTHER
Yuzuncu Yıl University
OTHER
Sanko University
OTHER
Antalya Training and Research Hospital
OTHER_GOV
Firat University
OTHER
Ankara Güven Hospital
UNKNOWN
Private Batman Hospital
UNKNOWN
İstanbul Bağcılar Training and Research Hospital
UNKNOWN
Istanbul Aydın University
OTHER
Mersin City Hospital
UNKNOWN
Baskent University Ankara Hospital
OTHER
Responsible Party
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Sezin Unal
Sezin Unal, MD
Principal Investigators
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Esin Koç, MD
Role: STUDY_DIRECTOR
Gazi University
Ahmet Y Bas, MD
Role: STUDY_DIRECTOR
Ankara Yildirim Beyazıt University
İbrahim M Hirfanoğlu, MD, PhD
Role: STUDY_DIRECTOR
Gazi University
Sezin Unal, MD
Role: STUDY_DIRECTOR
Baskent University
Locations
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Baskent University
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Esin Koc, Prof
Role: backup
Ahmet Y Bas, Prof
Role: backup
İbrahim M Hirfanoğlu, Prof
Role: backup
References
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Chiang MF, Quinn GE, Fielder AR, Ostmo SR, Paul Chan RV, Berrocal A, Binenbaum G, Blair M, Peter Campbell J, Capone A Jr, Chen Y, Dai S, Ells A, Fleck BW, Good WV, Elizabeth Hartnett M, Holmstrom G, Kusaka S, Kychenthal A, Lepore D, Lorenz B, Martinez-Castellanos MA, Ozdek S, Ademola-Popoola D, Reynolds JD, Shah PK, Shapiro M, Stahl A, Toth C, Vinekar A, Visser L, Wallace DK, Wu WC, Zhao P, Zin A. International Classification of Retinopathy of Prematurity, Third Edition. Ophthalmology. 2021 Oct;128(10):e51-e68. doi: 10.1016/j.ophtha.2021.05.031. Epub 2021 Jul 8.
Bas AY, Demirel N, Koc E, Ulubas Isik D, Hirfanoglu IM, Tunc T; TR-ROP Study Group. Incidence, risk factors and severity of retinopathy of prematurity in Turkey (TR-ROP study): a prospective, multicentre study in 69 neonatal intensive care units. Br J Ophthalmol. 2018 Dec;102(12):1711-1716. doi: 10.1136/bjophthalmol-2017-311789. Epub 2018 Mar 8.
Bas AY, Koc E, Dilmen U; ROP Neonatal Study Group. Incidence and severity of retinopathy of prematurity in Turkey. Br J Ophthalmol. 2015 Oct;99(10):1311-4. doi: 10.1136/bjophthalmol-2014-306286. Epub 2015 Apr 13.
Other Identifiers
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TR-ROP-2 Study
Identifier Type: -
Identifier Source: org_study_id
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