Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants with a BW >1500 Grs or GA ≥33 Wks in Turkey.
- Conditions
- Retinopathy of Prematurity
- Registration Number
- NCT06265363
- Lead Sponsor
- Baskent University Ankara Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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.
- Neonates who died before the first ROP examination are excluded from the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of ROP 12 months Incidence of ROP and severe ROP in infants \> 1500 gr and gestational age ≥ 33 weeks in Turkey.
- Secondary Outcome Measures
Name Time Method The role of chorioamnionitis in infants in the development of ROP 12 months The number of infants whose mothers with clinical/histological chorioamnionitis
Laser photocoagulation treatment 12 months Number of patients requiring laser photocoagulation treatment
Vitreoretinal surgery 12 months Number of patients requiring vitreoretinal surgery
The role of being SGA in infants in the development of ROP 12 months Number of infants with less than 10th percentile of birth weight according to Fenton graphs
The role of mechanical ventilation in infants in the development of ROP 12 months Duration of invasive mechanical ventilation during NICU admission
Anti-VEGF treatment 12 months Number of patients requiring anti-VEGF treatment
The role of sepsis in infants in the development of ROP 12 months Number of infants diagnosed with early sepsis (\< 3 days postnatal) or late sepsis (\>3 days postnatal) during the NICU admission
Trial Locations
- Locations (1)
Baskent University
🇹🇷Ankara, Turkey