An Eye-opener: The Impact of Eye Shields for Infants After Dilated Exam
试验速览
- 阶段
- 不适用
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Number of stress events
研究概览
简要总结
The eyes of hospitalized infants are often assessed by dilated exam, and there is evidence that infants experience post-exam stress. Investigators will evaluate whether eye shields for infants after dilated eye exam lessen stress and discomfort.
详细描述
Neonatal eye examinations are the standard of best practice in pediatrics. In the acute clinical setting, infants' eyes are inspected for eye development, defect, and disease. There is anecdotal and clinical evidence that infants experience stress after eye dilation. Investigators will evaluate whether eye shields for infants after dilated eye exam lessen stress and discomfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronological age 0-12 months
- •Infants who require dilated eye exams
- •Parent or legal guardian consent/permission granted
排除标准
- •More than a two-week interval between dilated eye exams
- •Prior or ongoing medical treatment or therapy for the eye(s)
- •Functional blindness diagnosed by eye exam
研究组 & 干预措施
No eye shields after dilated eye exam
Eye dilation for scheduled exam will be followed by routine clinical care.
Eye shields after dilated eye exam
Eye dilation for scheduled exam will be followed by routine clinical care and the application of eye shields. They will be worn until four (4) hours after the last dose of dilating eye drops.
干预措施: phototherapy eye shield (Device)
结局指标
主要结局
Number of stress events
时间窗: 4-6 hours (from first dose of eye dilating medication to four hours after last dose)
The primary outcome will be measured by the count of apneas and bradycardias (stress events) experienced by the infant during the period of eye dilation without eye shields as compared to the total stress events experienced when dilated eyes are covered with eye shields.
次要结局
- Number of stress events amongst covariates(4-6 hours (from first dose of eye dilating medication to four hours after last dose))
研究者
Maxine Ogbaa
BSN
Children's Hospital Los Angeles