Eye Shields for Infants After Dilated Exam

Pain Clinical Trial

Official title:

An Eye-opener: The Impact of Eye Shields for Infants After Dilated Exam

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04519060
• Other study ID #: CHLA-20-00211
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 2021

Study information

• Verified date: March 2021
• Source: Children's Hospital Los Angeles
• Contact: Maxine Ogbaa, BSN
• Phone: 323-361-2531
• Email: mogbaa[@]chla.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Infant, Newborn, Disease
• Infant, Newborn, Diseases
• Pain
• Retinopathy of Prematurity

Intervention

Device:
• phototherapy eye shield
Phototherapy eye shields will be applied to the eyes of infants dilated for scheduled eye exam. They will be worn until four (4) hours after the last dose of dilating eye drops.

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of stress events	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.	4-6 hours (from first dose of eye dilating medication to four hours after last dose)
Secondary	Number of stress events amongst covariates	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.	4-6 hours (from first dose of eye dilating medication to four hours after last dose)