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Hemodynamic Response to Pain During Retinopathy Of Prematurity Screening

NCT05666362 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-02-05

No results posted yet for this study

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

Interventions

DRUG

benoxinate hydrochloride 0.4% group

They will receive benoxinate hydrochloride 0.4% immediately before fundus

DRUG

saline 0.9% .

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

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Shimaa Hafez, MBChB · Faculty of medicine, Alexandria University, Egypt

  • Hesham Ghazal, PhD · Faculty of medicine, Alexandria University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-20
Primary Completion
2024-12-20
Completion
2025-01-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05666362 on ClinicalTrials.gov