Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants With a BW >1500 Grs or GA ≥33 Wks in Turkey. — TR-BigROP  

Retinopathy of Prematurity Clinical Trial

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. (TR-BigROP)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

• NCT number: NCT06265363
• Study type: Observational
• Source: Baskent University Ankara Hospital
• Contact: Sezin Unal
• Phone: 0090532
• Email: sezinunal@gmail.com
• Status: Recruiting
• Start date: August 1, 2023
• Completion date: November 1, 2024