Hemodynamic Response to Pain During Retinopathy Of Prematurity Screening

NCT05666362 | Completed Phase 4

• 1 other identifier: 0107389
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm

Outcome Measures

Primary Outcomes (2)

• 1-Clinical assessment:

  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):

  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)

Study Arms (2)

Group 1 : ( benoxinate hydrochloride 0.4% group )

ACTIVE COMPARATOR

They will receive benoxinate hydrochloride 0.4% immediately before fundus examination .

Drug: benoxinate hydrochloride 0.4% group

Group 2 : ( control group )

PLACEBO COMPARATOR

They will receive saline drops instead of benoxinate hydrochloride 0.4%. Randomization: simple randomization sampling using sealed envelope technique.

Drug: saline 0.9% .

Interventions

benoxinate hydrochloride 0.4% group DRUG

They will receive benoxinate hydrochloride 0.4% immediately before fundus

Group 1 : ( benoxinate hydrochloride 0.4% group )

saline 0.9% . DRUG

They will receive saline 0.9% before fundus examination in each eye .

Group 2 : ( control group )

Eligibility Criteria

• Age: 4 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Marwa Mohamed Farag

Alexandria, 0356, Egypt

Location

MeSH Terms

Conditions

Premature Birth

Interventions

benoxinate; Population Groups; Sodium Chloride

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Shimaa Hafez, MBChB

  Faculty of medicine, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Hesham Ghazal, PhD

  Faculty of medicine, Alexandria University, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine

Study Record Dates

• First Submitted: December 17, 2022
• First Posted: December 27, 2022
• Study Start: January 20, 2023
• Primary Completion: December 20, 2024
• Study Completion: January 15, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

EG (1)