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

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

Sponsors

Lead Sponsor: Aristotle University Of Thessaloniki

Source 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.

Overall Status Completed
Start Date September 3, 2019
Completion Date February 27, 2020
Primary Completion Date February 4, 2020
Phase N/A
Study Type Interventional
Primary Outcome
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 Outcome
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
Enrollment 37
Condition
Intervention

Intervention Type: Other

Intervention Name: Speculum-free (SpF) fundoscopy

Description: Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation

Arm Group Label: Study Group

Intervention Type: Other

Intervention Name: Speculum (Sp) fundoscopy

Description: Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation

Arm Group Label: Control Group

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 30 Weeks

Maximum Age: 37 Weeks

Healthy Volunteers: No

Location
Facility: "Papageorpiou" Hospital
Location Countries

Greece

Verification Date

May 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Aristotle University Of Thessaloniki

Investigator Full Name: Asimina Mataftsi

Investigator Title: Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Study Group

Type: Experimental

Description: ROPEE screening with speculum-free fundoscopy

Label: Control Group

Type: Active Comparator

Description: ROPEE screening with speculum fundoscopy

Acronym stressROP
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Screening

Masking: None (Open Label)

Source: ClinicalTrials.gov