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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No eye shields after dilated eye exam | No Intervention | Eye dilation for scheduled exam will be followed by routine clinical care. | |
| Eye shields after dilated eye exam | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phototherapy eye shield | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maxine Ogbaa, BSN | Contact | 323-361-2531 | mogbaa@chla.usc.edu | |
| Heidi Machen, PHN, BSN | Contact | 323-361-2531 | hmachen@chla.usc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Recruiting | Los Angeles | California | 90027 | United States |
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| ID | Term |
|---|---|
| D004194 | Disease |
| D010146 | Pain |
| D012178 | Retinopathy of Prematurity |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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|
| D012164 | Retinal Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |