Incidence, Risk Factors and Severity of Retinopathy of Prematurity (ROP) in Turkey
NCT ID: NCT02814929
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
6115 participants
OBSERVATIONAL
2016-04-01
2017-10-17
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 69 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 fertilisation, 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), weight gain at postnatal 28th days and breastfeeding.
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 69 NICUs will be pooled together and analyzed.
The "International Classification of ROP" guidelines are used to record stage of disease, location by zone, signs of plus disease and signs of regression. 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
Study Groups
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Demographic and Prenatal Characteristics
Gender, multiple pregnancy antenatal steroid therapy, invitro fertilisation, preeclampsia/eclampsia, infants of diabetic mother, chorioamnionitis will be compared among infants with and without ROP
No interventions assigned to this group
Neonatal Characteristics of infants
Neonatal characteristics: GA, BW, SGA, resuscitation in delivery room, RDS, duration of mechanical ventilation and oxygen therapy, intracranial hemorrhage, hemodynamically significant PDA, early/late sepsis, NEC, number of blood transfusions, BPD, breastfeeding and weight gain at postnatal 28th day will be compared among infants with and without ROP.
No interventions assigned to this group
Incidence of any ROP and severe ROP
Incidence of any ROP, severe ROP and its treatment in relation to BW and GA will be evaluated. The same parameters will also be evaluated in preterm babies of refugees.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
28 Days
ALL
No
Sponsors
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Acibadem Atakent University Hospital
OTHER
Baskent University
OTHER
Adana Numune Training and Research Hospital
OTHER_GOV
Aydin Adnan Menderes University
OTHER
Ankara University
OTHER
Baskent University Ankara Hospital
OTHER
Ankara Guven Hospital
UNKNOWN
Ataşehir Kadıkoy Sifa Hospital
UNKNOWN
Ataturk University
OTHER
Bagcilar Training and Research Hospital
OTHER_GOV
Bezmialem Vakif University
OTHER
Dortcelik Children Hospital
UNKNOWN
Uludag University
OTHER
Bulent Ecevit University
OTHER
Canakkale 18 Mart University
UNKNOWN
Cukurova University
OTHER
Denizli Devlet Hastanesi
OTHER
Denizli Ozel Saglik Hospital
UNKNOWN
Dicle University
OTHER
Dokuz Eylul University
OTHER
Doruk Bursa Hospital
UNKNOWN
Faruk Sukan Maternity and Children Hospital
UNKNOWN
Ege University
OTHER
Erzurum Nenehatun Maternity Hospital
UNKNOWN
Eskisehir Osmangazi University
OTHER
Firat University
OTHER
Cengiz Gokcek Women's and Children's Hospital
OTHER
University of Gaziantep
OTHER
Mustafa Kemal University
OTHER
Hacettepe University
OTHER
Istanbul Medeniyet University
OTHER
Istanbul Medipol University Hospital
OTHER
Istanbul University
OTHER
Dr. Behcet Uz Children's Hospital
OTHER
Kahramanmaras Megapark Hospital
OTHER
Kahramanmaras Sutcu Imam University
OTHER
Kanuni Sultan Suleyman Training and Research Hospital
OTHER
Karadeniz Technical University
OTHER
TC Erciyes University
OTHER
Kecioren Education and Training Hospital
OTHER
Kırıkkale University
OTHER
Konya Baskent University
UNKNOWN
Konya Meram State Hospital
OTHER
Selcuk University
OTHER
Dr. Lutfi Kirdar Kartal Training and Research Hospital
OTHER_GOV
Marmara University
OTHER
Medical Park Gaziantep Hospital
OTHER
Mersin Maternity Hospital
UNKNOWN
NCR International Hospital
UNKNOWN
Necmettin Erbakan University
OTHER
Ozel Medova Hospital
UNKNOWN
Pamukkale University
OTHER
Umraniye Education and Research Hospital
OTHER_GOV
Inonu University
OTHER
Sami Ulus Maternity and Children Hospital
UNKNOWN
Ondokuz Mayıs University
OTHER
Suleymaniye Birth And Women's Health Education And Research Hospital
OTHER_GOV
Sisli Hamidiye Etfal Training and Research Hospital
OTHER
Tepecik Training and Research Hospital
OTHER
Tokat Gaziosmanpasa University
OTHER
Trabzon Kanuni Education and Research Hospital
OTHER
Trakya University
OTHER
Yuksek Ihtisas University
OTHER
Yuzuncu Yıl University
OTHER
Zekai Tahir Burak Women's Health Research and Education Hospital
OTHER
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
OTHER
Muğla Sıtkı Koçman University
OTHER
Koç University
OTHER
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
OTHER
Responsible Party
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Ahmet Yagmur BAS
Neonatologist
Principal Investigators
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Ahmet Y Bas, MD
Role: PRINCIPAL_INVESTIGATOR
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
Nihal Demirel, MD
Role: PRINCIPAL_INVESTIGATOR
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
İbrahim M Hirfanoglu, MD
Role: PRINCIPAL_INVESTIGATOR
Gazi University
Dilek U Isik, MD
Role: PRINCIPAL_INVESTIGATOR
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
Turan Tunc, MD
Role: PRINCIPAL_INVESTIGATOR
Istanbul
Esin Koc, MD
Role: PRINCIPAL_INVESTIGATOR
Gazi University
Locations
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Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
Ankara, Keçi̇ören, Turkey (Türkiye)
Countries
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References
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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.
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.
Other Identifiers
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Turkey ROP Study
Identifier Type: -
Identifier Source: org_study_id
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