Incidence, Risk Factors and Severity of Retinopathy of Prematurity (ROP) in Turkey (TR-ROP)

Incidence, Risk Factors and Severity of Retinopathy of Prematurity (ROP) in Turkey: A Prospective Multicenter Study Including 69 NICUs

The study includes preterm infants who are being screened for ROP between April 1,2016 and April 30, 2017 in 69 neonatal intensive care units (NICUs) in Turkey. Infants with birth weight (BW) of ≤1500 g or ≤32 weeks' gestation and those with a BW of greater than 1500 g or gestational age (GA) >32 weeks with an unstable clinical course 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.

Study Overview

• Status: Completed
• Conditions: Retinopathy of Prematurity

Detailed Description

This study, promoted by the "Turkish Neonatology Society", involved preterm infants who are being screened for ROP between April 1, 2016 and April 30, 2017 in level III Turkish NICUs.

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.

• Study Type: Observational
• Enrollment (Actual): 6115

Contacts and Locations

Study Locations

• Turkey
  • Keçi̇ören
    • Ankara, Keçi̇ören, Turkey, 06100
      • Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Preterm babies screened for ROP.

Description

Inclusion Criteria:

• Infants with BW ≤1500 g or ≤32 weeks' gestation and those with a BW of greater than 1500 g or GA >32 weeks requiring cardiorespiratory support and who were determined by the attending clinician to be at risk for ROP, are included.

Exclusion Criteria:

• Neonates who died before the first ROP examination are excluded from the study.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ROP in Turkey	Incidence of ROP and severe ROP in relation to GA and BW in Turkey	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The association of antenatal corticosteroid administration with ROP		12 months
The role of sepsis in infants in the development of ROP	Culture proven and clinical early and late sepsis will be evaluated	12 months
The relationship between rate of postnatal weight gain and severity of ROP		12 months
The relationship between breastfeeding and ROP development		12 months
ROP in SGA premature infants	Comparison of ROP in SGA infants with those of appropriate size for GA	12 months
ROP in multiple births	Comparison of the frequency and severity of ROP among singleton and multiple-birth neonates	12 months
The role of transfusions in ROP development		12 months
Duration of oxygen therapy among infants with and without ROP		12 months
Number of patients requiring laser photocoagulation treatment		12 months
Number of patients requiring vitreoretinal surgery		12 months
Number of patients requiring anti-vascular endothelial growth factor treatment		12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ROP in preterm babies of refugees in Turkey	Incidence of any ROP and severe ROP in relation to GA and BW in preterm babies of refugees	12 months

Collaborators and Investigators

• Sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
• Collaborators: Pamukkale University; Hacettepe University; Cukurova University; Kanuni Sultan Suleyman Training and Research Hospital; Baskent University; Marmara University; Zeynep Kamil Maternity and Pediatric Research and Training Hospital; Ataturk University; Bezmialem Vakif University; Muğla Sıtkı Koçman University; Yuzuncu Yıl University; Istanbul University; Bulent Ecevit University; Mustafa Kemal University; Selcuk University; Koç University; TC Erciyes University; Ege University; Dokuz Eylul University; Inonu University; Kahramanmaras Sutcu Imam University; Sisli Hamidiye Etfal Training and Research Hospital; Tokat Gaziosmanpasa University; Necmettin Erbakan University; Firat University; Ondokuz Mayıs University; Istanbul Medeniyet University; Zekai Tahir Burak Women's Health Research and Education Hospital; Bagcilar Training and Research Hospital; Tepecik Training and Research Hospital; Istanbul Medipol University Hospital; Uludag University; University of Gaziantep; Eskisehir Osmangazi University; Ankara University; Trakya University; Aydin Adnan Menderes University; Kırıkkale University; Karadeniz Technical University; Baskent University Ankara Hospital; Konya Meram State Hospital; Umraniye Education and Research Hospital; Kecioren Education and Training Hospital; Medical Park Gaziantep Hospital; Cengiz Gokcek Women's and Children's Hospital; Adana Numune Training and Research Hospital; Trabzon Kanuni Education and Research Hospital; Yuksek Ihtisas University; Suleymaniye Birth And Women's Health Education And Research Hospital; Dr. Behcet Uz Children's Hospital; Dr. Lutfi Kirdar Kartal Training and Research Hospital; Dicle University; Acibadem Atakent University Hospital; NCR International Hospital; Ankara Güven Hospital; Ataşehir Kadıkoy Sifa Hospital; Dortcelik Children Hospital; Canakkale 18 Mart University; Denizli Devlet Hastanesi; Denizli Ozel Saglik Hospital; Doruk Bursa Hospital; Faruk Sukan Maternity and Children Hospital; Erzurum Nenehatun Maternity Hospital; Kahramanmaras Megapark Hospital; Konya Baskent University; Mersin Maternity Hospital; Ozel Medova Hospital; Sami Ulus Maternity and Children Hospital
• Investigators: Principal Investigator: Ahmet Y Bas, MD, Etlik Zubeyde Hanim Womens' Health and Teaching Hospital; Principal Investigator: Nihal Demirel, MD, Etlik Zubeyde Hanim Womens' Health and Teaching Hospital; Principal Investigator: İbrahim M Hirfanoglu, MD, Gazi University; Principal Investigator: Dilek U Isik, MD, Etlik Zubeyde Hanim Womens' Health and Teaching Hospital; Principal Investigator: Turan Tunc, MD, Istanbul; Principal Investigator: Esin Koc, MD, Gazi University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): October 17, 2017

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (Estimated): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: ROP; Incidence; Risk factors; Turkey
• Additional Relevant MeSH Terms: Eye Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Retinal Diseases; Premature Birth; Retinopathy of Prematurity
• Other Study ID Numbers: Turkey ROP Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO