Hemodynamic Response to Pain During Retinopathy Of Prematurity Screening

NCT ID: NCT05666362

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-20
• Study Completion Date: 2025-01-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 : ( benoxinate hydrochloride 0.4% group )

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

Group Type: ACTIVE_COMPARATOR

benoxinate hydrochloride 0.4% group

Intervention Type: DRUG

They will receive benoxinate hydrochloride 0.4% immediately before fundus

Group 2 : ( control group )

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

Group Type: PLACEBO_COMPARATOR

saline 0.9% .

Intervention Type: DRUG

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

Interventions

benoxinate hydrochloride 0.4% group

They will receive benoxinate hydrochloride 0.4% immediately before fundus

Intervention Type: DRUG

saline 0.9% .

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Mohamed Farag

Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shimaa Hafez, MBChB

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine, Alexandria University, Egypt

Hesham Ghazal, PhD

Role: STUDY_DIRECTOR

Faculty of medicine, Alexandria University, Egypt

Locations

Marwa Mohamed Farag

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0107389

Identifier Type: -

Identifier Source: org_study_id