Effect of Benoxinate Hydrochloride Eye Drops on The Premature Infant Pain Profile Score During Retinopathy of Prematurity Screening

Retinopathy of Prematurity Clinical Trial

Official title:

Effect of Benoxinate Hydrochloride Eye Drops on The Premature Infant Pain Profile Score During Retinopathy of Prematurity Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06461975
• Other study ID #: Benoxinate drops for ROP exam
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2024
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 1, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Days to 90 Days

Eligibility

Inclusion Criteria:

• Preterm infants with GA =34 weeks and/or with birth weight =2000 g

• 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 on muscle relaxants, analgesics, sedatives, or exogenous steroids

• Infants who required mechanical ventilation or continuous positive airway pressure at the first examination

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PIPP score	The PIPP is a composite measure that includes seven indicators, each of which is rated on a four-point scale (0-3). The indicators include heart rate, oxygen saturation, GA, brow bulge, nasolabial furrow, behavioural state, and eye squeeze. Larger number indicates more stress (worse outcome)	1-3 month after birth