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

June 11, 2024 updated by: Islam Shereen Hamdy, Alexandria University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Faculty of Medicine Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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 Names:
  • "Polyfresh ®"
Experimental: 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
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.
Other Names:
  • "Benox ®"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PIPP score
Time Frame: 1-3 month after birth
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Islam Ahmed, M.D., University of Alexandria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Benoxinate drops for ROP exam

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data are available and owned by the authors and can be shared upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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