Hemodynamic Response to Pain During Retinopathy Of Prematurity Screening

Preterm Clinical Trial

Official title:

Hemodynamic Response Of Premature Brain To Pain During Retinopathy Of Prematurity Screening: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05666362
• Other study ID #: 0107389
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: January 2024
• Source: Alexandria University
• Contact: Marwa mohamed Farag, PhD
• Phone: 01288681788
• Email: d.marwa.farag[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 1, 2024
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Weeks to 12 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Preterm
• Retinopathy of Prematurity

Intervention

Drug:
• benoxinate hydrochloride 0.4% group
They will receive benoxinate hydrochloride 0.4% immediately before fundus
• saline 0.9% .
They will receive saline 0.9% before fundus examination in each eye .

Locations

Country	Name	City	State
Egypt	Marwa Mohamed Farag	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)