Eye Shields for Infants After Dilated Exam

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Retinopathy of prematurity
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Brief Title

Eye Shields for Infants After Dilated Exam

Official Title

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

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.

Study Type

Interventional

Primary Outcome

Number of stress events

Secondary Outcome

 Number of stress events amongst covariates

Condition

Infant, Newborn, Disease

Intervention

phototherapy eye shield

Study Arms / Comparison Groups

 No eye shields after dilated eye exam
Description:  Eye dilation for scheduled exam will be followed by routine clinical care.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

106

Start Date

February 1, 2021

Completion Date

December 2021

Primary Completion Date

October 2021

Eligibility Criteria

        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

Gender

All

Ages

N/A - 1 Year

Accepts Healthy Volunteers

No

Contacts

, 323-361-2531, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT04519060

Organization ID

CHLA-20-00211

Responsible Party

Principal Investigator

Study Sponsor

Children's Hospital Los Angeles

Study Sponsor

, ,

Verification Date

March 2021