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

Not Applicable

Completed

• Conditions: Retinopathy of Prematurity
• Interventions: Other: Speculum (Sp) fundoscopy; Other: Speculum-free (SpF) fundoscopy

• Registration Number: NCT04408807
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Study Timeline

• Study Start: 2019-09-03
• Primary Completion: 2020-02-04
• Study Completion: 2020-02-27
• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-05-29
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control Group	Speculum (Sp) fundoscopy	ROPEE screening with speculum fundoscopy
Study Group	Speculum-free (SpF) fundoscopy	ROPEE screening with speculum-free fundoscopy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Crying score of the Bernese pain scale	During the examination

Trial Locations

Locations (1)

"Papageorgiou" Hospital; 🇬🇷 Thessaloniki, Greece