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Eye Shields for Infants After Dilated Exam

Primary Purpose

Infant, Newborn, Disease, Pain, Retinopathy of Prematurity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
phototherapy eye shield
Sponsored by
Children's Hospital Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Newborn, Disease focused on measuring eye shield, eye protector, eye patch, eye mask, phototherapy

Eligibility Criteria

undefined - 1 Year (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital Los AngelesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No eye shields after dilated eye exam

Eye shields after dilated eye exam

Arm Description

Eye dilation for scheduled exam will be followed by routine clinical care.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 17, 2020
Last Updated
March 10, 2021
Sponsor
Children's Hospital Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT04519060
Brief Title
Eye Shields for Infants After Dilated Exam
Official Title
An Eye-opener: The Impact of Eye Shields for Infants After Dilated Exam
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Newborn, Disease, Pain, Retinopathy of Prematurity, Eye Diseases
Keywords
eye shield, eye protector, eye patch, eye mask, phototherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No eye shields after dilated eye exam
Arm Type
No Intervention
Arm Description
Eye dilation for scheduled exam will be followed by routine clinical care.
Arm Title
Eye shields after dilated eye exam
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
phototherapy eye shield
Other Intervention Name(s)
phototherapy eye protector, phototherapy eye mask
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of stress events
Description
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.
Time Frame
4-6 hours (from first dose of eye dilating medication to four hours after last dose)
Secondary Outcome Measure Information:
Title
Number of stress events amongst covariates
Description
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.
Time Frame
4-6 hours (from first dose of eye dilating medication to four hours after last dose)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maxine Ogbaa, BSN
Phone
323-361-2531
Email
mogbaa@chla.usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Machen, PHN, BSN
Phone
323-361-2531
Email
hmachen@chla.usc.edu
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxine Ogbaa, BSN
Phone
323-361-2531
Email
mogbaa@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Heidi Machen, PHN, BSN
Phone
323-361-2531
Email
hmachen@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Maxine Ogbaa, BSN
First Name & Middle Initial & Last Name & Degree
Heidi Machen, PHN, BSN

12. IPD Sharing Statement

Plan to Share IPD
No

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Eye Shields for Infants After Dilated Exam

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