Retinopathy of Prematurity
Conditions
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 (speculum-free, SpF) is less painful/stressful than funduscopy with speculum (Sp) and scleral indentation.
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. A random number table was used to allocate participants into either a) receiving Sp funduscopy on their first and SpF on their second screening examination a week later, or b) receiving SpF first and Sp a week later.
Interventions
OTHERSpeculum-free (SpF) fundoscopy
Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation
OTHERSpeculum (Sp) fundoscopy
Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Weeks to 37 Weeks
Healthy volunteers
No
Inclusion criteria
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 criteria
1. Severe clinical condition with unstable vital signs to the extent that stress is not desired and the examination need to be postponed. 2. Diagnosis of traumatic apoptosis of the corneal epithelium / corneal ulcer. 3. Neonates under sedative/analgesic treatment. 4. Intraventricular hemorrhage (III,IV degree), moderate/severe neurological impairment, other conditions that could alter pain response.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Premature Infant Pain Profile-Revised score (PIPP) | a) before the intervention [the effect of mydriasis (PIPP1)] b) at the end of the intervention [the effect of funduscopy (PIPP2)] c) 10-20 minutes after the intervention [the overall effect of the examination, i.e. mydriasis and funduscopy (PIPP3)] |
Secondary
| Measure | Time frame |
|---|---|
| Crying score of the Bernese pain scale | During the examination |
| Adverse events including arrythmia/bradycardia, apnoea, increased oxygen demands and feed intolerance | During the examination and during the 24 hours after the examination |
| Adequacy of judging the presence of treatment-requiring ROP | At the end of ROPEE screening |
| Duration of fundoscopy | During the examination |
Countries
Greece
Outcome results
None listed