Hemodynamic Response to Pain During Retinopathy Of Prematurity Screening

Alexandria University68 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Preterm

Interventions

benoxinate hydrochloride 0.4% groupDRUG

They will receive benoxinate hydrochloride 0.4% immediately before fundus

saline 0.9% .DRUG

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

Eligibility

Sex: ALLMin age: 4 WeeksMax age: 12 Weeks

Medical Language ↔ Plain English

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.

Locations (1)

Marwa Mohamed Farag

Alexandria, Egypt

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: 28 days postnatal age (time of screen of retinopathy of prematurity ,ROP)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.