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

• Sponsor: Aristotle University Of Thessaloniki (Other)
• Overall Status: Completed
• CT.gov ID: NCT04408807
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.8
• Patients Per Site Per Month: 6.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinopathy of Prematurity	Other: Speculum-free (SpF) fundoscopy; Other: Speculum (Sp) fundoscopy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided
• Actual Study Start Date: Sep 3, 2019
• Actual Primary Completion Date: Feb 4, 2020
• Actual Study Completion Date: Feb 27, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Crying score of the Bernese pain scale [During the examination]

2. Adverse events including arrythmia/bradycardia, apnoea, increased oxygen demands and feed intolerance [During the examination and during the 24 hours after the examination]

3. Adequacy of judging the presence of treatment-requiring ROP [At the end of ROPEE screening]

4. Duration of fundoscopy [During the examination]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Weeks to 37 Weeks
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	"Papageorgiou" Hospital	Thessaloniki		Greece

Sponsors and Collaborators

• Aristotle University Of Thessaloniki

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Dhaliwal CA, Wright E, McIntosh N, Dhaliwal K, Fleck BW. Pain in neonates during screening for retinopathy of prematurity using binocular indirect ophthalmoscopy and wide-field digital retinal imaging: a randomised comparison. Arch Dis Child Fetal Neonatal Ed. 2010 Mar;95(2):F146-8. doi: 10.1136/adc.2009.168971. Epub 2009 Oct 8.
• Dhillon B, Wright E, Fleck BW. Screening for retinopathy of prematurity: are a lid speculum and scleral indentation necessary? J Pediatr Ophthalmol Strabismus. 1993 Nov-Dec;30(6):377-81.
• Mehta M, Adams GG, Bunce C, Xing W, Hill M. Pilot study of the systemic effects of three different screening methods used for retinopathy of prematurity. Early Hum Dev. 2005 Apr;81(4):355-60. Epub 2004 Dec 8.
• Mukherjee AN, Watts P, Al-Madfai H, Manoj B, Roberts D. Impact of retinopathy of prematurity screening examination on cardiorespiratory indices: a comparison of indirect ophthalmoscopy and retcam imaging. Ophthalmology. 2006 Sep;113(9):1547-52. Epub 2006 Jul 7.

• Responsible Party: Asimina Mataftsi, Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus, Aristotle University Of Thessaloniki
• ClinicalTrials.gov Identifier: NCT04408807
• Other Study ID Numbers: 414/08-05-2019
• First Posted: May 29, 2020
• Last Update Posted: Mar 24, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth

Study Results

No Results Posted as of Mar 24, 2022