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

March 23, 2022 updated by: Asimina Mataftsi, Aristotle University Of Thessaloniki
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece
        • "Papageorgiou" Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 8 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study Group
ROPEE screening with speculum-free fundoscopy
Other: Speculum-free (SpF) fundoscopy
Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation
ACTIVE_COMPARATOR: Control Group
ROPEE screening with speculum fundoscopy
Other: Speculum (Sp) fundoscopy
Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Premature Infant Pain Profile-Revised score (PIPP)
Time Frame: 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)]
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
Time Frame
Crying score of the Bernese pain scale
Time Frame: During the examination
During the examination
Adverse events including arrythmia/bradycardia, apnoea, increased oxygen demands and feed intolerance
Time Frame: During the examination and during the 24 hours after the examination
During the examination and during the 24 hours after the examination
Adequacy of judging the presence of treatment-requiring ROP
Time Frame: At the end of ROPEE screening
At the end of ROPEE screening
Duration of fundoscopy
Time Frame: During the examination
During the examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 3, 2019

Primary Completion (ACTUAL)

February 4, 2020

Study Completion (ACTUAL)

February 27, 2020

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (ACTUAL)

May 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 414/08-05-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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