Clinical trial NCT06265363: Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants with a BW >1500 Grs or GA ≥33 Wks in Turkey.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinopathy of Prematurity
Lead sponsor: Baskent University Ankara Hospital
Sponsor class: OTHER
Collaborators: name: Hacettepe University
name: Gazi University
name: Gaziosmanpasa Research and Education Hospital
name: Celal Bayar University
name: Selcuk University
name: Recep Tayyip Erdogan University
name: Karadeniz Technical University
name: Istinye University
name: Biruni University
name: T.C. ORDU ÜNİVERSİTESİ
name: Dr. Lutfi Kirdar Kartal Training and Research Hospital
name: Pamukkale University
name: Kanuni Sultan Suleyman Training and Research Hospital
name: Konya City Hospital
name: Kecioren Education and Training Hospital
name: Ataturk University
name: Meda Hospital
name: Eskisehir Osmangazi University
name: Necmettin Erbakan University
name: Kırıkkale University
name: Sisli Hamidiye Etfal Training and Research Hospital
name: Acibadem Atakent University Hospital
name: Balikesir Ataturk City Hospital
name: Kocaeli University
name: Acibadem Maslak Hospital
name: Erzurum City Hospital
name: Afyon Karahisar Hospital
name: Ankara Koru Hospital
name: Gulhane School of Medicine
name: Bursa Yüksek İhtisas Education and Research Hospital
name: Namik Kemal University
name: Bursa City Hospital
name: Kayseri City Hospital
name: Ankara Etlik City Hospital
name: Zonguldak Bulent Ecevit University
name: Gazi Yasargil Training and Research Hospital
name: Inonu University
name: Dr. Behcet Uz Children's Hospital
name: Ankara Training and Research Hospital
name: Tepecik Training and Research Hospital
name: Aydin Adnan Menderes University
name: Dicle University
name: Akdeniz University
name: Umraniye Education and Research Hospital
name: Ankara City Hospital Bilkent
name: Afyonkarahisar University of Health Sciences Health Application and Research Center
name: Harran University
name: Sanliurfa Mehmet Akif Inan Education and Research Hospital
name: Istanbul University - Cerrahpasa
name: Uludag University
name: şanlıurfa training and research Hospital
name: Dokuz Eylul University
name: Bursa Doruk Yıldırım Hospital
name: Malatya Turgut Ozal University
name: Abant Izzet Baysal University
name: Alanya Training and Research Hospital
name: İstanbul Training and Research Hospital
name: Baskent Univeristy Adana Hospital
name: Kahramanmaras Sutcu Imam University
name: Batman Training and Research Hospital
name: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
name: Acıbadem Atunizade Hospital
name: Adiyaman Training and Research Hospital
name: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
name: Ondokuz Mayıs University
name: Trakya University
name: Trabzon Kanuni Education and Research Hospital
name: Seyhan Hospital
name: Esenyurt University Hospital
name: Başakşehir Çam & Sakura City Hospital
name: Sakarya University
name: Mardin Training and Research Hospital
name: Karabuk University
name: Giresun Training and Research Hospital
name: Koc University Hospital
name: Tekirdağ City Hospital
name: Medipol University Mega Hospital
name: Adana City Training and Research Hospital
name: Istanbul University
name: Marmara University Pendik Training and Research Hospital
name: Medikal Park Ankara Hospital
name: Medipol University Bahcelievler Hospital
name: Muğla Sıtkı Koçman University
name: Yuzuncu Yıl University
name: Sanko University
name: Antalya Training and Research Hospital
name: Firat University
name: Ankara Güven Hospital
name: Private Batman Hospital
name: İstanbul Bağcılar Training and Research Hospital
name: Istanbul Aydın University
name: Mersin City Hospital
First posted: 2024-02-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 28
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants with BW \>1500 g or ≥33 weeks' gestation who were screened for ROP.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of ROP
timeFrame: 12 months
Secondary outcomes:
measure: The role of being SGA in infants in the development of ROP
timeFrame: 12 months
measure: The role of sepsis in infants in the development of ROP
timeFrame: 12 months
measure: The role of mechanical ventilation in infants in the development of ROP
timeFrame: 12 months
measure: The role of chorioamnionitis in infants in the development of ROP
timeFrame: 12 months
measure: Laser photocoagulation treatment
timeFrame: 12 months
measure: Anti-VEGF treatment
timeFrame: 12 months
measure: Vitreoretinal surgery
timeFrame: 12 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
affiliation: Gazi University
name: Esin Koç, MD
role: STUDY_DIRECTOR
affiliation: Ankara Yildirim Beyazıt University
name: Ahmet Y Bas, MD
role: STUDY_DIRECTOR
affiliation: Gazi University
name: İbrahim M Hirfanoğlu, MD, PhD
role: STUDY_DIRECTOR
affiliation: Baskent University
name: Sezin Unal, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.