Back to resultsStress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided (stressROP)
Primary Purpose
Retinopathy of Prematurity
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Speculum-free (SpF) fundoscopy
Speculum (Sp) fundoscopy
Sponsored by
About this trial
This is an interventional screening trial for Retinopathy of Prematurity
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:
- 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.
Sites / Locations
- "Papageorgiou" Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study Group
Control Group
Arm Description
ROPEE screening with speculum-free fundoscopy
ROPEE screening with speculum fundoscopy
Outcomes
Primary Outcome Measures
Premature Infant Pain Profile-Revised score (PIPP)
Secondary Outcome Measures
Crying score of the Bernese pain scale
Adverse events including arrythmia/bradycardia, apnoea, increased oxygen demands and feed intolerance
Adequacy of judging the presence of treatment-requiring ROP
Duration of fundoscopy
Full Information
NCT ID
NCT04408807
First Posted
May 26, 2020
Last Updated
March 23, 2022
Sponsor
Aristotle University Of Thessaloniki
1. Study Identification
Unique Protocol Identification Number
NCT04408807
Brief Title
Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided
Acronym
stressROP
Official Title
Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
February 4, 2020 (Actual)
Study Completion Date
February 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
ROPEE screening with speculum-free fundoscopy
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
ROPEE screening with speculum fundoscopy
Intervention Type
Other
Intervention Name(s)
Speculum-free (SpF) fundoscopy
Intervention Description
Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation
Intervention Type
Other
Intervention Name(s)
Speculum (Sp) fundoscopy
Intervention Description
Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation
Primary Outcome Measure Information:
Title
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)]
Secondary Outcome Measure Information:
Title
Crying score of the Bernese pain scale
Time Frame
During the examination
Title
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
Title
Adequacy of judging the presence of treatment-requiring ROP
Time Frame
At the end of ROPEE screening
Title
Duration of fundoscopy
Time Frame
During the examination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
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:
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.
Facility Information:
Facility Name
"Papageorgiou" Hospital
City
Thessaloniki
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19815939
Citation
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.
Results Reference
background
PubMed Identifier
16828505
Citation
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. doi: 10.1016/j.ophtha.2006.03.056. Epub 2006 Jul 7.
Results Reference
background
PubMed Identifier
15814220
Citation
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. doi: 10.1016/j.earlhumdev.2004.09.005. Epub 2004 Dec 8.
Results Reference
background
PubMed Identifier
8120743
Citation
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. doi: 10.3928/0191-3913-19931101-08.
Results Reference
background
PubMed Identifier
34939742
Citation
Mataftsi A, Lithoxopoulou M, Seliniotaki AK, Talimtzi P, Oustoglou E, Diamanti E, Soubasi V, Ziakas N, Haidich AB. Avoiding use of lid speculum and indentation reduced infantile stress during retinopathy of prematurity examinations. Acta Ophthalmol. 2022 Feb;100(1):e128-e134. doi: 10.1111/aos.15085. Epub 2021 Dec 23.
Results Reference
result
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Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided
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