Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided

Conditions
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Retinopathy of Prematurity

Intervention / Treatment
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* Other: Speculum-free (SpF) fundoscopy
* Other: Speculum (Sp) fundoscopy


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 30 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>ROPEE screening with speculum-free fundoscopy | Other: Speculum-free (SpF) fundoscopy<br>* Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation<br>|
| Active Comparator: Control Group<br>ROPEE screening with speculum fundoscopy | Other: Speculum (Sp) fundoscopy<br>* Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |