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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incidence of ROP
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 28 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Neonates who died before the first ROP examination are excluded from the study.
结局指标
主要结局
Incidence of ROP
时间窗: 12 months
Incidence of ROP and severe ROP in infants \> 1500 gr and gestational age ≥ 33 weeks in Turkey.
次要结局
- Anti-VEGF treatment(12 months)
- The role of chorioamnionitis in infants in the development of ROP(12 months)
- Laser photocoagulation treatment(12 months)
- Vitreoretinal surgery(12 months)
- The role of being SGA in infants in the development of ROP(12 months)
- The role of mechanical ventilation in infants in the development of ROP(12 months)
- The role of sepsis in infants in the development of ROP(12 months)
研究者
Sezin Unal
Sezin Unal, MD
Baskent University Ankara Hospital