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| Name | Class |
|---|---|
| Hacettepe University | OTHER |
| Gazi University | OTHER |
| Gaziosmanpasa Research and Education Hospital | OTHER_GOV |
| Manisa Celal Bayar University |
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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.
This study, promoted by the "Turkish Neonatology Society", involved preterm infants who are being screened for ROP between August 1,2023 and August 1, 2024 in level III/IV Turkish NICUs.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ROP | Incidence of ROP and severe ROP in infants > 1500 gr and gestational age ≥ 33 weeks in Turkey. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The role of being SGA in infants in the development of ROP | Number of infants with less than 10th percentile of birth weight according to Fenton graphs | 12 months |
| The role of sepsis in infants in the development of ROP |
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Inclusion Criteria:
Exclusion Criteria:
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Infants with BW >1500 g or ≥33 weeks' gestation who were screened for ROP.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sezin Unal | Contact | 0090532 | sezinunal@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Esin Koç, MD | Gazi University | Study Director |
| Ahmet Y Bas, MD | Ankara Yildirim Beyazıt University | Study Director |
| İbrahim M Hirfanoğlu, MD, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baskent University | Recruiting | Ankara | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34247850 | Result | 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. | |
| 29519879 |
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| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
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| 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 |
| Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital | OTHER |
| 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 |
| Sanliurfa Education and Research Hospital | OTHER_GOV |
| 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 |
| Istanbul Medipol University Hospital | OTHER |
| Adana City Training and Research Hospital | OTHER |
| Istanbul University | OTHER |
| Marmara University Pendik Training and Research Hospital | OTHER |
| Medikal Park Ankara Hospital | UNKNOWN |
| Muğla Sıtkı Koçman University | OTHER |
| Yuzuncu Yil University | OTHER |
| Sanko University | OTHER |
| Antalya Training and Research Hospital | OTHER_GOV |
| Firat University | OTHER |
| Ankara Guven Hospital | OTHER |
| Private Batman Hospital | UNKNOWN |
| İstanbul Bağcılar Training and Research Hospital | UNKNOWN |
| Istanbul Aydın University | OTHER |
| Mersin City Hospital | UNKNOWN |
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Number of infants diagnosed with early sepsis (< 3 days postnatal) or late sepsis (>3 days postnatal) during the NICU admission
| 12 months |
| The role of mechanical ventilation in infants in the development of ROP | Duration of invasive mechanical ventilation during NICU admission | 12 months |
| The role of chorioamnionitis in infants in the development of ROP | The number of infants whose mothers with clinical/histological chorioamnionitis | 12 months |
| Laser photocoagulation treatment | Number of patients requiring laser photocoagulation treatment | 12 months |
| Anti-VEGF treatment | Number of patients requiring anti-VEGF treatment | 12 months |
| Vitreoretinal surgery | Number of patients requiring vitreoretinal surgery | 12 months |
| Gazi University |
| Study Director |
| Sezin Unal, MD | Baskent University | Study Director |
| Result |
| 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. |
| 25868788 | Result | 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. |
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |