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Eye Shields for Infants After Dilated Exam

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ClinicalTrials.gov Identifier: NCT04519060
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Maxine Ogbaa, Children's Hospital Los Angeles

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infant, Newborn, Disease Pain Retinopathy of Prematurity Eye Diseases Device: phototherapy eye shield Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Eye-opener: The Impact of Eye Shields for Infants After Dilated Exam
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: No eye shields after dilated eye exam
Eye dilation for scheduled exam will be followed by routine clinical care.
Experimental: Eye shields after dilated eye exam
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.
 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.
Other Names:
  • phototherapy eye protector
  • phototherapy eye mask


Outcome Measures
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Primary Outcome Measures :
  1. Number of stress events [ Time Frame: 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 Outcome Measures :
  1. Number of stress events amongst covariates [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04519060


Contacts
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Contact: Maxine Ogbaa, BSN 323-361-2531 mogbaa@chla.usc.edu
Contact: Heidi Machen, PHN, BSN 323-361-2531 hmachen@chla.usc.edu

Locations
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United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Maxine Ogbaa, BSN    323-361-2531    mogbaa@chla.usc.edu   
Contact: Heidi Machen, PHN, BSN    323-361-2531    hmachen@chla.usc.edu   
Principal Investigator: Maxine Ogbaa, BSN         
Sub-Investigator: Heidi Machen, PHN, BSN         
Sponsors and Collaborators
Children's Hospital Los Angeles
More Information
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Responsible Party: Maxine Ogbaa, BSN, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT04519060    
Other Study ID Numbers: CHLA-20-00211
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maxine Ogbaa, Children's Hospital Los Angeles:
eye shield
eye protector
eye patch
eye mask
phototherapy
Additional relevant MeSH terms:
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Eye Diseases
Retinopathy of Prematurity
Infant, Newborn, Diseases
Retinal Diseases
Infant, Premature, Diseases