An observational study to access the relationship between retinopathy of prematurity and thrombocytopenia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- To access the development and progression of ROP in thrombocytopenic participants.
研究概览
简要总结
it is an observational study being conducted at SMS Medical college and Hospital,at department of ophthalmology and paediatrics to access the relationship between retinopathy of prematurity and thrombocytopenia. Patients will be recruited from neonatal ICU of pediatrics department and those coming to ophthalmology department for ROP screening. On first visit patients will classified into thrombocytopenic and non thrombocytopenic. after applying inclusion and exclusion criteria these patients will be followed up subsequently to see what proportion them develop ROP and will be divided into the ones requiring treatment and not requiring treatment. Also it will be noted how many of them change their category from ROP to No ROP and from requiring treatment to not requiring treatment. Examination will be done by using Indirect ophthalmoscope and panretinal 2.2 lens.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Day(s) 至 3.00 Month(s)（—）
- 性别
- All
入选标准
- •with gestational age at delivery of less than 30 weeks birth weight of less than 1500 grams considered to be under risk in terms of ROP by the neonatologist discretion (eg.
- •infants with hypotension or those who received oxygen supplementation) Whose legal parents agreed for the informed consent.
排除标准
- •No final ROP outcome documentation.
- •Death before examination.
- •Loss to follow up.
结局指标
主要结局
To access the development and progression of ROP in thrombocytopenic participants.
时间窗: To access the development and progression of ROP in thrombocytopenic participants at 1st visit, 3 weeks, 6 weeks, 9 weeks and 12 weeks.
次要结局
未报告次要终点
研究者
Dr Sunil Kumar Gurjar
SMS Medical College and Hospital, Jaipur