Screening and result analysis of retinopathy of prematurity in premature and low birth weight neonates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence rate will be calculated
研究概览
简要总结
• With written and informed consent of the parents
newborn will be examined.
• Detailed history will be taken specially birth weight,
gestational age, any complication during delivery.
• Both the eyes will be examined under torch light for
any gross anterior segment abnormality.
• If direct pupillary reflex is normal then both eyes will
be dilated using diluted Tropicamide(0.4%) +
Phenylephrine(2.5%) eye drops .
• Drops will be instilled three times 10 minutes apart.
While instlling mydriatic eye drop pulse monitor
will be attached to look for pulse and blood
pressure of the child.
• Excess drops immediately blotted to decrease
systemic absorption and side effects.
Retina of both eyes will be examined one by one
using sterile pediatric eye speculum after instilling
1 drop of topical anesthetic eye drop
(paracaine(0.5%)).
• Indirect ophthalmoscopy will be performed using
zeiss indirect ophthalmoscope with 28 D lens.
• All the quadrants of both the eyes will be
examined and charted.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 1.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients whose parents are giving written and informed consent for examining their child.
- •New born of gestational age less than 34 weeks or birth weight less than or equal to 2000 g Any baby of gestational age less than 37 weeks or birth weight less than or equal to 2000 g with any of following Sepsis Acute respiratory distress syndrome Multiple blood transfusions Multiple births.
排除标准
- •Parents who are not giving written and informed consent.
- •Patient having very poor general condition.
- •Patient having other congenital anomalies of eye.
结局指标
主要结局
Incidence rate will be calculated
时间窗: Incidence rate will be calculated | in different neonate groups. According to their gestational age. 36 week of gestational age will be landmark till that screening must be done.
in different neonate groups.
时间窗: Incidence rate will be calculated | in different neonate groups. According to their gestational age. 36 week of gestational age will be landmark till that screening must be done.
次要结局
未报告次要终点