Eye Shields for Infants After Dilated Exam

Not Applicable

• Conditions: Eye Diseases; Pain; Retinopathy of Prematurity; Infant, Newborn, Disease
• Interventions: Device: phototherapy eye shield

• Registration Number: NCT04519060
• Lead Sponsor: Children's Hospital Los Angeles

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 Timeline

• Study First Submitted: 2020-05-17
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-19
• Study Start: 2021-02-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-12
• Primary Completion: 2021-10
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Eye shields after dilated eye exam	phototherapy eye shield	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.

Primary Outcome Measures

Name	Time	Method
Number of stress events	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 Outcome Measures

Name	Time	Method
Number of stress events amongst covariates	4-6 hours (from first dose of eye dilating medication to four hours after last dose)	The secondary outcome measure will be abstracted from covariate data (e.g., infant gestational age at birth, post-natal age, weight, and ventilation status) to assess the influence of covariables on the response to eye shields as an intervention to lessen stress and discomfort in hospitalized infants after dilated eye exam.

Trial Locations

Locations (1)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States