Status:
COMPLETED
The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Unity Health Toronto
Conditions:
Retinopathy of Prematurity
Pain
Eligibility:
All Genders
Phase:
NA
Brief Summary
Although screening exams for retinopathy of prematurity (ROP) prevent blindness they are physiologically stressful for infants. The investigators postulate that photosensitivity during mydriasis contr...
Detailed Description
Retinopathy of Prematurity (ROP) is a disorder of retinal vascular development of the low birthweight preterm infant that may lead to blindness if untreated. The long term visual acuity of infants wit...
Eligibility Criteria
Inclusion
- Infant with birthweight of ≤1500 g or less or a gestational age of ≤ 32 weeks with no prior ROP screening. Examinations will be performed starting at either 4 weeks chronological age or 31 weeks post menstrual age, whichever is later.
Exclusion
- Pre-existing corneal abrasion/ulcers, ocular malformations that prevent dilation, and known neurological abnormalities that could affect response to pain.
- Anticipation of transfer to another institution.
- Prior ROP screening
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2017
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03824782
Start Date
April 1 2016
End Date
June 30 2017
Last Update
January 31 2019
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada