Ignite Creation Date:
2024-07-17 @ 10:56 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461975
Status:
COMPLETED
Last Update Posted:
2024-06-17
First Post:
2024-06-06
Brief Title:
Effect of Benoxinate Hydrochloride Eye Drops on The Premature Infant Pain Profile Score During Retinopathy of Prematurity Screening
Sponsor:
Alexandria University
Organization:
Alexandria University
Study Overview
Official Title:
Effect of Benoxinate Hydrochloride Eye Drops on The Premature Infant Pain Profile Score During Retinopathy of Prematurity Screening
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aims To evaluate the effects of topical Benoxinate HCL eye drops on the Premature Infant Pain Profile PIPP scores in infants undergoing Retinopathy of Prematurity ROP screening
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
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
Detailed Description:
Aims To evaluate the effects of topical Benoxinate HCL eye drops on Premature Infant Pain Profile PIPP scores in infants undergoing Retinopathy of Prematurity ROP screening
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None