An Eye-opener: The Impact of Eye Shields for Infants After Dilated Exam
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Number of stress events
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 1 Year (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Chronological age 0-12 months
- •Infants who require dilated eye exams
- •Parent or legal guardian consent/permission granted
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: phototherapy eye shield (Device)
Outcomes
Primary Outcomes
Number of stress events
Time Frame: 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.
Secondary Outcomes
- Number of stress events amongst covariates(4-6 hours (from first dose of eye dilating medication to four hours after last dose))
Investigators
Maxine Ogbaa
BSN
Children's Hospital Los Angeles