Status:
COMPLETED
Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided
Lead Sponsor:
Aristotle University Of Thessaloniki
Conditions:
Retinopathy of Prematurity
Eligibility:
All Genders
30-37 years
Phase:
NA
Brief Summary
The purpose is to assess the hypothesis that indirect ophthalmoscopy for retinopathy of prematurity eye examination (ROPEE) screening without the use of a lid speculum and scleral indentation (speculu...
Detailed Description
A prospective randomized cross-over study was conducted for the comparison of the two techniques of funduscopy for ROPEE screening, i.e. with (Sp) or without (SpF) the use of a speculum and indentor. ...
Eligibility Criteria
Inclusion
- Preterm neonates undergoing screening for ROP, i.e.
- with GA \< 32weeks and/or BW \< 1501grams
- infants of greater BW and GA with increased comorbidity, e.g. sepsis, prolonged need for oxygen supplementation etc., as judged by the attending neonatologist
Exclusion
- Severe clinical condition with unstable vital signs to the extent that stress is not desired and the examination need to be postponed.
- Diagnosis of traumatic apoptosis of the corneal epithelium / corneal ulcer.
- Neonates under sedative/analgesic treatment.
- Intraventricular hemorrhage (III,IV degree), moderate/severe neurological impairment, other conditions that could alter pain response.
Key Trial Info
Start Date :
September 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2020
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04408807
Start Date
September 3 2019
End Date
February 27 2020
Last Update
March 24 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
"Papageorgiou" Hospital
Thessaloniki, Greece