Pain Clinical Trial
Official title:
An Eye-opener: The Impact of Eye Shields for Infants After Dilated Exam
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Los Angeles |
United States,
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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