Incidence, Risk Factors and Severity of Retinopathy of Prematurity (ROP) in Turkey: A Prospective Multicenter Study Including 69 NICUs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,115
- 试验地点
- 1
- 主要终点
- Incidence of ROP in Turkey
研究概览
简要总结
The study includes preterm infants who are being screened for ROP between April 1,2016 and April 30, 2017 in 69 neonatal intensive care units (NICUs) in Turkey. Infants with birth weight (BW) of ≤1500 g or ≤32 weeks' gestation and those with a BW of greater than 1500 g or gestational age (GA) >32 weeks with an unstable clinical course 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 April 1, 2016 and April 30, 2017 in level III Turkish NICUs.
An electronic questionnaire is being filled by certified neonatologists in Turkey via a special network. Neonatologists working in 69 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 fertilisation, 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), weight gain at postnatal 28th days and breastfeeding.
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.
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 ≤32 weeks' gestation and those with a BW of greater than 1500 g or GA >32 weeks requiring cardiorespiratory support and who were determined by the attending clinician to be at risk for ROP, are included.
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 in Turkey
时间窗: 12 months
Incidence of ROP and severe ROP in relation to GA and BW in Turkey
次要结局
- The association of antenatal corticosteroid administration with ROP(12 months)
- The role of transfusions in ROP development(12 months)
- Number of patients requiring laser photocoagulation treatment(12 months)
- Number of patients requiring anti-vascular endothelial growth factor treatment(12 months)
- Number of patients requiring vitreoretinal surgery(12 months)
- The role of sepsis in infants in the development of ROP(12 months)
- The relationship between rate of postnatal weight gain and severity of ROP(12 months)
- ROP in SGA premature infants(12 months)
- ROP in multiple births(12 months)
- Duration of oxygen therapy among infants with and without ROP(12 months)
- The relationship between breastfeeding and ROP development(12 months)
研究者
Ahmet Yagmur BAS
Neonatologist
Ankara Yildirim Beyazıt University