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 |
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| 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. |
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| 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. |
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| 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 |
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| Secondary Outcome |
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| 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 |
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| 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 |
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| Location |
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| Location Countries |
Greece |
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| Verification Date |
May 2020 |
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| 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 |
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| 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 |
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| Acronym | stressROP | ||||||||||
| Patient Data | No | ||||||||||
| Study Design Info |
Allocation: Randomized Intervention Model: Crossover Assignment Primary Purpose: Screening Masking: None (Open Label) |
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