Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants with a BW >1500 Grs or GA ≥33 Wks in Turkey. (TR-ROP-2)

Evaluation of the Frequency of Retinopathy of Prematurity, Influencing Risk Factors, and Treatment Outcomes in Premature Infants with a Birth Weight >1500 Grams or Gestational Age ≥33 Weeks in Turkey.

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.

Study Overview

• Status: Recruiting
• Conditions: Retinopathy of Prematurity

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Sezin Unal; Phone Number: 0090532; Email: sezinunal@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Baskent University
    • Contact: Sezin Unal; Phone Number: 0090532; Email: sezinunal@gmail.com
    • Contact: Esin Koc, Prof
    • Contact: Ahmet Y Bas, Prof
    • Contact: İbrahim M Hirfanoğlu, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Infants with BW >1500 g or ≥33 weeks' gestation who were screened for ROP.

Description

Inclusion Criteria:

• Infants with BW >1500 g or ≥33 weeks' gestation who were determined to be at risk for ROP by the attending clinician and were screened for ROP.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Baskent University Ankara Hospital
• Collaborators: Pamukkale University; Hacettepe University; Kanuni Sultan Suleyman Training and Research Hospital; Gazi University; Zeynep Kamil Maternity and Pediatric Research and Training Hospital; Ataturk University; Muğla Sıtkı Koçman University; Yuzuncu Yıl University; Istanbul University; Selcuk University; Ankara Training and Research Hospital; Akdeniz University; Dokuz Eylul University; Inonu University; Kahramanmaras Sutcu Imam University; Antalya Training and Research Hospital; Istanbul Training and Research Hospital; Sisli Hamidiye Etfal Training and Research Hospital; Necmettin Erbakan University; Firat University; Ondokuz Mayıs University; T.C. ORDU ÜNİVERSİTESİ; Kocaeli University; Adana City Training and Research Hospital; Abant Izzet Baysal University; Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital; Tepecik Training and Research Hospital; Gaziosmanpasa Research and Education Hospital; Uludag University; Eskisehir Osmangazi University; Trakya University; Celal Bayar University; Sanliurfa Mehmet Akif Inan Education and Research Hospital; Aydin Adnan Menderes University; Biruni University; Kırıkkale University; Istinye University; Karadeniz Technical University; Marmara University Pendik Training and Research Hospital; Karabuk University; Sakarya University; Zonguldak Bulent Ecevit University; Malatya Turgut Ozal University; Umraniye Education and Research Hospital; Bursa Yüksek İhtisas Education and Research Hospital; Sanko University; Istanbul Aydın University; Kecioren Education and Training Hospital; Bursa City Hospital; Namik Kemal University; Harran University; Istanbul University - Cerrahpasa (IUC); Trabzon Kanuni Education and Research Hospital; Koç University Hospital; Kayseri City Hospital; Konya City Hospital; Dr. Behcet Uz Children's Hospital; Dr. Lutfi Kirdar Kartal Training and Research Hospital; Erzurum City Hospital; Dicle University; Batman Training and Research Hospital; Acibadem Atakent University Hospital; Ankara Etlik City Hospital; Acıbadem Atunizade Hospital; Acibadem Maslak Hospital; Recep Tayyip Erdogan University; Ankara Guven Hospital; Ankara Bilkent City Hospital; Meda Hospital; Balikesir Ataturk City Hospital; Afyon Karahisar Hospital; Ankara Koru Hospital; University of Health Sciences Gulhane Hospital; Gazi Yasargil Training and Research Hospital; Afyonkarahisar University of Health Sciences Health Application and Research Center; şanlıurfa training and research Hospital; Bursa Doruk Yıldırım Hospital; Alanya Training and Research Hospital; Baskent Univeristy Adana Hospital; Adiyaman Training and Research Hospital; Seyhan Hospital; Esenyurt University Hospital; Mardin Training and Research Hospital; Giresun Training and Research Hospital; Tekirdağ City Hospital; Medipol University Mega Hospital; Medikal Park Ankara Hospital; Medipol University Bahcelievler Hospital; Private Batman Hospital; İstanbul Bağcılar Training and Research Hospital; Mersin City Hospital; Başakşehir Çam & Sakura City Hospital
• Investigators: Study Director: Esin Koç, MD, Gazi University; Study Director: Ahmet Y Bas, MD, Ankara Yildirim Beyazıt University; Study Director: İbrahim M Hirfanoğlu, MD, PhD, Gazi University; Study Director: Sezin Unal, MD, Baskent University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 10, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Infant, Premature, Diseases; Infant, Newborn, Diseases; Eye Diseases; Premature Birth; Retinal Diseases; Retinopathy of Prematurity
• Other Study ID Numbers: TR-ROP-2 Study

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No