Hemodynamic Response to Pain During Retinopathy Of Prematurity Screening

Sponsor

Alexandria University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05666362

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm	Drug: benoxinate hydrochloride 0.4% group Drug: saline 0.9% .	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 20, 2022

Anticipated Primary Completion Date :

May 20, 2023

Anticipated Study Completion Date :

Aug 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 : ( benoxinate hydrochloride 0.4% group ) They will receive benoxinate hydrochloride 0.4% immediately before fundus examination .	Drug: benoxinate hydrochloride 0.4% group They will receive benoxinate hydrochloride 0.4% immediately before fundus
Placebo Comparator: Group 2 : ( control group ) They will receive saline drops instead of benoxinate hydrochloride 0.4%. Randomization: simple randomization sampling using sealed envelope technique.	Drug: saline 0.9% . They will receive saline 0.9% before fundus examination in each eye .

Arm

Intervention/Treatment

Active Comparator: Group 1 : ( benoxinate hydrochloride 0.4% group )

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

Drug: benoxinate hydrochloride 0.4% group

They will receive benoxinate hydrochloride 0.4% immediately before fundus

Placebo Comparator: Group 2 : ( control group )

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

Drug: saline 0.9% .

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Weeks to 12 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marwa Mohamed Farag	Alexandria		Egypt	0356

Sponsors and Collaborators

Alexandria University

Investigators

Principal Investigator: Shimaa Hafez, MBChB, Faculty of medicine, Alexandria University, Egypt
Study Director: Hesham Ghazal, PhD, Faculty of medicine, Alexandria University, Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marwa Mohamed Farag, Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine, Alexandria University

ClinicalTrials.gov Identifier:

NCT05666362

Other Study ID Numbers:

0107389

First Posted:

Dec 27, 2022

Last Update Posted:

Jan 3, 2023

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinopathy of Prematurity

Benoxinate

Study Results

No Results Posted as of Jan 3, 2023