Comparing safety of two drug regimens for pupillary dilatation for retinopathy of prematurity screening in preterm neonates: A double blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- a 3-step combination of
研究概览
简要总结
· Retinopathy of prematurity (ROP) is a common complication related to preterm neonates. Various dilatation protocols are being used for mydriasis during ROP screening. We aim to compare the safety of two mydriatic regimens using 0.5% Tropicamide two times followed by 2.5% Phenylephrine+ 0.5% Tropicamide (intervention group) Vs combination of 2.5% Phenylephrine+ 0.5% Tropicamide used thrice (control group). We hypothesize that using the 3-step combination of 0.5% tropicamide plus 0.5% tropicamide plus 0.5% tropicamide+2.5% phenylephrine eye drops for pupillary dilatation in preterm neonates undergoing ROP screening will result in 50% less increase in the diastolic blood pressure and heart rate at 15+5 minutes after screening, when compared to use of 0.5 % tropicamide+ 2.5% phenylephrine combination eye drops used thrice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Month(s) 至 5.00 Month(s)（—）
- 性别
- All
入选标准
- •Gestational age at birth is less than 34 weeks or birth weight <1500 gm.
排除标准
- •Major malformation
- •Hemodynamic instability
- •Suspicion of cardiovascular disease
- •Anatomical variations of the anterior segment
- •Consent denied by the parents/ attendants.
结局指标
主要结局
a 3-step combination of
时间窗: 15 minutes after the retinopathy of prematurity screening procedure
0.5% tropicamide plus 0.5% tropicamide followed by 2.5% phenylephrine+0.5%
时间窗: 15 minutes after the retinopathy of prematurity screening procedure
thrice will cause 50% less increase in diastolic
时间窗: 15 minutes after the retinopathy of prematurity screening procedure
blood pressure
时间窗: 15 minutes after the retinopathy of prematurity screening procedure
tropicamide vs. a combination of 2.5% phenylephrine+0.5% tropicamide used
时间窗: 15 minutes after the retinopathy of prematurity screening procedure
次要结局
- To compare the mydriatic efficacy and suitability of pupillary dilatation by assessing the need for rescue dose of the two mydriatic regimens being compared.(Before ROP screening (after instillation of mydriatic drops) to 24 hrs after)