Effect of Benoxinate Hydrochloride Eye Drops on The Premature Infant Pain Profile Score During Retinopathy of Prematurity Screening
NCT ID: NCT06461975
Last Updated: 2024-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
88 participants
INTERVENTIONAL
2023-01-01
2023-06-01
Brief Summary
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Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Dilated fundus examination was done in Group A infants using the tear substitute eye drops and the second using the Benoxinate HCL drops and the reversed order of drops for Group B. Video recording of the pulse oximeter monitor, the face and the body of the infant were analyzed by a single neonatology consultant for Premature Infant Pain Profile (PIPP) scoring 1 minute before, during the examination of the first eye, 1 minute and 5 minutes after the conclusion of the examination of the second eye. The sound of the ophthalmologist on the video recordings indicating the time of the lid speculum insertion, the shining of the indirect ophthalmoscope light without indentation and the scleral indentation would aid in assessing the differences of the PIPP indicators during each step of the examination.
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Detailed Description
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Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Dilated fundus examination was done in Group A infants using the tear substitute eye drops and the second using the Benoxinate HCL drops and the reversed order of drops for Group B. Video recording of the pulse oximeter monitor, the face and the body of the infant were analyzed by a single neonatology consultant for Premature Infant Pain Profile (PIPP) scoring 1 minute before, during the examination of the first eye, 1 minute and 5 minutes after the conclusion of the examination of the second eye. The sound of the ophthalmologist on the video recordings indicating the time of the lid speculum insertion, the shining of the indirect ophthalmoscope light without indentation and the scleral indentation would aid in assessing the differences of the PIPP indicators during each step of the examination.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
QUADRUPLE
Study Groups
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Tear substitute in first exam
Te first examination was done using the tear substitute eye drops and the second using the Benoxinate HCL drops given just before the ROP screening.
artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops.
The second group had the first examination done using the Benoxinate HCL drops "Benox ®" eye drops and the second using the tear substitute "Polyfresh ®"given just before the ROP screening.
Benoxinate HCL in first exam
infants in Group B had the reversed order of the drops in the two examinations. the first examination done using the Benoxinate HCL drops and the second using the tear substitute eye drops
Benoxinate Hydrochloride
The first group had the first examination done using the tear substitute "Polyfresh ®" eye drops and the second using the Benoxinate HCL drops "Benox ®" given just before the ROP screening.
Interventions
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Benoxinate Hydrochloride
The first group had the first examination done using the tear substitute "Polyfresh ®" eye drops and the second using the Benoxinate HCL drops "Benox ®" given just before the ROP screening.
artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops.
The second group had the first examination done using the Benoxinate HCL drops "Benox ®" eye drops and the second using the tear substitute "Polyfresh ®"given just before the ROP screening.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Preterm infants with larger GA or birth weight who were at increased risk of ROP according to the attending neonatologist
* Infants were believed to require at least 2 ROP screenings
Exclusion Criteria
* Infants who required mechanical ventilation or continuous positive airway pressure at the first examination
28 Days
90 Days
ALL
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Islam Shereen Hamdy
Associate Professor
Principal Investigators
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Islam Ahmed, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Alexandria
Locations
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Faculty of Medicine Alexandria University
Alexandria, , Egypt
Countries
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Other Identifiers
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Benoxinate drops for ROP exam
Identifier Type: -
Identifier Source: org_study_id
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