European Disease Registry on Retinopathy of Prematurity (ROP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 48
- 主要终点
- Baseline data of preterm born infants who develop treatment-requiring retinopathy of prematurity
研究概览
简要总结
The EU-ROP registry is a European wide multicenter non-interventional observational registry study intended to run open-ended in as many countries as possible including infants treated for retinopathy of prematurity irrespective of the used treatment modality. The registry is strictly observational; only clinical routine data is collected, no study-specific examinations or interventions are to be performed.
The aim of the EU-ROP registry is to collect information on as many patients as possible treated for ROP in Europe. Both the number of study centers as well as the number of patients to be included into the registry are not limited.
The primary objective is to describe the typical clinical features of infants with severe ROP, variations in phenotype, and the clinical progression of the disease over time (natural history) in different European countries as well as to study treatment patterns, follow-up patterns, as well as long-term outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ROP requiring treatment according to the respective national ROP screening and treatment guidelines
排除标准
- •Denial or absence of consent for documentation and electronic storage of personal data by parents or legal guardians
结局指标
主要结局
Baseline data of preterm born infants who develop treatment-requiring retinopathy of prematurity
时间窗: Birth to treatment of ROP, an average of 12 weeks
Birth weight, gestational age, weight at treatment, comorbidities (e.g. sepsis, necrotizing enterocolitis)
ROP stage
时间窗: Through follow-up after treatment, an average of 1 year postnatal age
Stage of ROP at treatment and during follow-up
Treatment parameters at initial treatment
时间窗: An average of 12 weeks postnatal age
Type of treatment
Treatment parameters at re-treatment
时间窗: Through study completion, an average of 20 to 30 weeks postnatal age
Type of treatment
次要结局
- Long-term neurologic development(Up to 18 years)
- Long-term ophthalmic development(Up to 18 years)