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

NCT06461975 | Completed Phase 3

• 1 other identifier: Benoxinate drops for ROP exam
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinopathy of Prematurity

Keywords

Infant stress; Retinopathy of prematurity; Benoxinate hydrochloride; PIPP score

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Tear substitute in first exam

EXPERIMENTAL

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.

Drug: artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops.

Benoxinate HCL in first exam

EXPERIMENTAL

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

Drug: Benoxinate Hydrochloride

Interventions

Benoxinate Hydrochloride DRUG

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.

Also known as: "Benox ®"

Benoxinate HCL in first exam

artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops. DRUG

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.

Also known as: "Polyfresh ®"

Tear substitute in first exam

Eligibility Criteria

• Age: 28 Days - 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Infants on muscle relaxants, analgesics, sedatives, or exogenous steroids
• Infants who required mechanical ventilation or continuous positive airway pressure at the first examination

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine Alexandria University

Alexandria, Egypt

Location

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

benoxinate; Lubricant Eye Drops; Hyaluronic Acid; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Islam Ahmed, M.D.

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A dedicated clinical pharmacist placed the topical benoxinate HCL (Benox ®, Removed for facilitating the blinded review). and the artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops (Polyfresh ®, Removed for facilitating the blinded review) in identical bottles, each of them had a code that was changed every clinic and was not known to the examining ophthalmologist, the nurse in charge of swaddling the baby and putting the drops or the attending neonatologist monitoring the infant and recording the PIPP score. The clinical pharmacist would ensure that crossover was performed in the second examination of every study child.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective, observational, double-blinded, cross-over

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 17, 2024
• Study Start: January 1, 2023
• Primary Completion: April 30, 2023
• Study Completion: June 1, 2023
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)