Eye Diseases, Infant, Newborn, Disease, Pain, Retinopathy of Prematurity
Conditions
Keywords
eye shield, eye protector, eye patch, eye mask, phototherapy
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.
Interventions
DEVICEphototherapy 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.
Sponsors
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactMaxine Ogbaa, BSN
Backup ContactHeidi Machen, PHN, BSN
Outcome results
None listed