Efficiency and Safety of Phenylephrine and Tropicamide Used in Premature Retinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- The mean pupillary diameter
研究概览
简要总结
Because of the neonatologists reported that some infants had suffered from vomiting, bradycardia, hypotonia, and aspiration risk about 30-60 minutes after the fundus examination in the intensive care unit. The investigators observed the pupil dilation effects and side effects of tipple instillation of phenylephrine 2.5% plus tropicamide 0.5% ophthalmic drop combination which the investigators routinely used in ROP examination.
详细描述
Purpose: To determine effect and vital change after topical application of phenylephrine 2.5% and tropicamide 0.5% three times for retinopathy of prematurity (ROP) examination in preterm infants.
Methods: Pupillary diameter, blood pressure, pulse rate, and oxygen saturation were monitored before, and after up to 24 hours 60 ROP screening examinations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 32 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants who were first ROP examinations
- •infants born before 32 weeks.
排除标准
- •Developmental ocular and/or systemic anomalies.
- •Drug use that can affect vital values
- •Unstable general condition
- •Food intolerance
- •Recurrent vomiting.
结局指标
主要结局
The mean pupillary diameter
时间窗: an average of 1 year
will be measured with a ruler after 60 minutes instillation of mydriatic
次要结局
未报告次要终点
研究者
Atilla Alpay
Asociate Pofessor Atilla Alpay
Bulent Ecevit University