Hemodynamic Response to Pain During Retinopathy Of Prematurity Screening

Phase 4

Completed

• Conditions: Preterm
• Interventions: Drug: saline 0.9% .; Drug: benoxinate hydrochloride 0.4% group

• Registration Number: NCT05666362
• Lead Sponsor: Alexandria University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-17
• Study First Submitted QC: 2022-12-17
• Study First Posted: 2022-12-27
• Study Start: 2023-01-20
• Primary Completion: 2024-12-20
• Study Completion: 2025-01-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 : ( control group )	saline 0.9% .	They will receive saline drops instead of benoxinate hydrochloride 0.4%. Randomization: simple randomization sampling using sealed envelope technique.
Group 1 : ( benoxinate hydrochloride 0.4% group )	benoxinate hydrochloride 0.4% group	They will receive benoxinate hydrochloride 0.4% immediately before fundus examination .

Primary Outcome Measures

Name	Time	Method
1-Clinical assessment:	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).
2-Near-infrared spectroscopy (NIRS):	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.

Trial Locations

Locations (1)

Marwa Mohamed Farag; 🇪🇬 Alexandria, Egypt