Hemodynamic Response to Pain During Retinopathy Of Prematurity Screening

February 3, 2025 updated by: Marwa Mohamed Farag, Alexandria University

Hemodynamic Response Of Premature Brain To Pain During Retinopathy Of Prematurity Screening: A Randomized Controlled Trial

Study of cerebral hemodynamic changes in preterm infant and the effect of topical anesthetic eye drops ( benoxinate hydrochloride 0.4% ) on PIPP score and cerebral hemodynamic changes during fundus examination in neonates with gestational age ≤ 34 weeks or birth weight ≤ 2.000 Kg regardless their gestational age , after postnatal day 28.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

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, 0356
        • Marwa Mohamed Farag

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

4 weeks to 2 months (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Preterm infants with gestational age ≤34 weeks or infant with birth weight ≤ 2.000 Kg regardless their gestational age,with postnatal age ≥ 28 days undergoing routine ROP screening.

Exclusion Criteria:

Patients with any of the following will be excluded at the time of assessment:

  • Evidence of intrauterine infection (TORCH).
  • Chromosomal abnormalities.
  • Major congenital anomalies.
  • Major brain pathology such as Grade 3-4 intraventricular hemorrhage and periventricular leukomalacia.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 : ( benoxinate hydrochloride 0.4% group )
They will receive benoxinate hydrochloride 0.4% immediately before fundus examination .
Drug: benoxinate hydrochloride 0.4% group
They will receive benoxinate hydrochloride 0.4% immediately before fundus
Placebo Comparator: Group 2 : ( control group )
They will receive saline drops instead of benoxinate hydrochloride 0.4%. Randomization: simple randomization sampling using sealed envelope technique.
Drug: saline 0.9% .
They will receive saline 0.9% before fundus examination in each eye .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-Clinical assessment:
Time Frame: 28 days postnatal age (time of screen of retinopathy of prematurity ,ROP)
Pain score will be evaluated by using the premature infant pain profile (PIPP) assessed by the caring bedside nurse during fundus examination. It consists of heart rate(beat/minute), peripheral oxygen saturation in the right hand(%), and mean arterial blood pressure (mmHg).
28 days postnatal age (time of screen of retinopathy of prematurity ,ROP)
2-Near-infrared spectroscopy (NIRS):
Time Frame: 28 days postnatal age (time of screen of retinopathy of prematurity ,ROP)
Measurements of cerebral oxygenation (crSO2) in (%) will be done by using near infrared spectroscopy (NIRS), device (INVOSTM 5100C Cerebral/ Somatic Oximeter Monitor; Covidien) by placing a neonatal brain sensor on the right frontoparietal area of the scalp.
28 days postnatal age (time of screen of retinopathy of prematurity ,ROP)

Collaborators and Investigators

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

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Shimaa Hafez, MBChB, Faculty of Medicine, Alexandria University, Egypt
  • Study Director: Hesham Ghazal, PhD, Faculty of Medicine, Alexandria University, Egypt

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 20, 2023

Primary Completion (Actual)

December 20, 2024

Study Completion (Actual)

January 15, 2025

Study Registration Dates

First Submitted

December 17, 2022

First Submitted That Met QC Criteria

December 17, 2022

First Posted (Actual)

December 27, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0107389

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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