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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04519060
Other study ID # CHLA-20-00211
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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