Back to resultsHemodynamic Response to Pain During Retinopathy Of Prematurity Screening
Primary Purpose
Preterm
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
benoxinate hydrochloride 0.4% group
saline 0.9% .
Sponsored by
About this trial
This is an interventional treatment trial for Preterm
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.
Sites / Locations
- Marwa Mohamed FaragRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group 1 : ( benoxinate hydrochloride 0.4% group )
Group 2 : ( control group )
Arm Description
They will receive benoxinate hydrochloride 0.4% immediately before fundus examination .
They will receive saline drops instead of benoxinate hydrochloride 0.4%. Randomization: simple randomization sampling using sealed envelope technique.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05666362
First Posted
December 17, 2022
Last Updated
December 29, 2022
Sponsor
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT05666362
Brief Title
Hemodynamic Response to Pain During Retinopathy Of Prematurity Screening
Official Title
Hemodynamic Response Of Premature Brain To Pain During Retinopathy Of Prematurity Screening: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2022 (Actual)
Primary Completion Date
May 20, 2023 (Anticipated)
Study Completion Date
August 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1 : ( benoxinate hydrochloride 0.4% group )
Arm Type
Active Comparator
Arm Description
They will receive benoxinate hydrochloride 0.4% immediately before fundus examination .
Arm Title
Group 2 : ( control group )
Arm Type
Placebo Comparator
Arm Description
They will receive saline drops instead of benoxinate hydrochloride 0.4%. Randomization: simple randomization sampling using sealed envelope technique.
Intervention Type
Drug
Intervention Name(s)
benoxinate hydrochloride 0.4% group
Intervention Description
They will receive benoxinate hydrochloride 0.4% immediately before fundus
Intervention Type
Drug
Intervention Name(s)
saline 0.9% .
Intervention Description
They will receive saline 0.9% before fundus examination in each eye .
Primary Outcome Measure Information:
Title
1-Clinical assessment:
Description
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)
Title
2-Near-infrared spectroscopy (NIRS):
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa mohamed Farag, PhD
Phone
01288681788
Ext
+2
Email
d.marwa.farag@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Islam Shereen Hamdy, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shimaa Hafez, MBChB
Organizational Affiliation
Faculty of medicine, Alexandria University, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hesham Ghazal, PhD
Organizational Affiliation
Faculty of medicine, Alexandria University, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Marwa Mohamed Farag
City
Alexandria
ZIP/Postal Code
0356
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marwa Mohamed Farag, PhD
Phone
01288681788
Ext
02
Email
d.marwa.farag@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Hemodynamic Response to Pain During Retinopathy Of Prematurity Screening
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