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Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates

Primary Purpose

Hypoxic Encephalopathy, Birth Asphyxia, Neonatal Encephalopathy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Passive cooling application
cooling using Blanket roll III
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypoxic Encephalopathy focused on measuring therapeutic hypothermia, asphyxiated neonates, tissue Doppler

Eligibility Criteria

1 Hour - 6 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Evidence of perinatal/intrapartum hypoxia, as indicated by at least one of: Apgar score of less than or equal to 5 at 10 minutes Needing mechanical ventilation or ongoing resuscitation at 10 minutes PH in cord blood gas is less than 7.00 or a base excess worse than or equal to minus 12 mmol /L on cord/arterial/venous/capillary blood gas obtained within 60 minutes of birth. Evidence of moderate or severe encephalopathy. Greater than or equal to 35 weeks gestational age. Birth weight greater than or equal to 1800 g. Able to begin cooling before 6 hours of birth. Exclusion Criteria: Congenital cyanotic heart disease. Multiple congenital anomalies. Birth asphyxia's babies after start of cooling with cardiovascular instability.

Sites / Locations

  • Marwa Mohamed Farag

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group I: (passive cooling group)

Group II: (Blanket roll III cooling group)

Arm Description

Outcomes

Primary Outcome Measures

Myocardial function through using tissue Doppler (TD).
neonatal echocardiography using a (Vivid IQ) with a (3-8 MHz) with software for Tissue Doppler imaging (TDI) , myocardial performance index and measuring velocities of different waveforms, cm/sec.
Left ventricular function through using conventional echocardiography.
Ejection fraction in percent .

Secondary Outcome Measures

Right ventricular function using conventional echocardiography
TAPSE (tricuspid annular plane systolic excursion) in mm .

Full Information

First Posted
November 25, 2022
Last Updated
May 12, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05652738
Brief Title
Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates
Official Title
The Impact of Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
April 20, 2023 (Actual)
Study Completion Date
May 1, 2023 (Actual)

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
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Studying the effect of passive versus Blanket roll III modality of therapeutic hypothermia (TH)on myocardial function of asphyxiated neonates through using tissue Doppler (TD).
Detailed Description
A clinical trial study of 100 Gestational-age-matched asphyxiated cooled neonates will divided into two groups, 50 in each group for comparison the myocardial function using passive cooling and BLANKET ROLL III as modality of TH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic Encephalopathy, Birth Asphyxia, Neonatal Encephalopathy, Hypothermia, Newborn
Keywords
therapeutic hypothermia, asphyxiated neonates, tissue Doppler

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I: (passive cooling group)
Arm Type
Active Comparator
Arm Title
Group II: (Blanket roll III cooling group)
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Passive cooling application
Intervention Description
Passive cooling application for asphyxiated neonates and their effect on myocardial function and hemodynamics
Intervention Type
Device
Intervention Name(s)
cooling using Blanket roll III
Intervention Description
standard care using Blanket roll III in asphyxiated neonates and their effect on myocardial function and hemodynamics
Primary Outcome Measure Information:
Title
Myocardial function through using tissue Doppler (TD).
Description
neonatal echocardiography using a (Vivid IQ) with a (3-8 MHz) with software for Tissue Doppler imaging (TDI) , myocardial performance index and measuring velocities of different waveforms, cm/sec.
Time Frame
first 4 days of life
Title
Left ventricular function through using conventional echocardiography.
Description
Ejection fraction in percent .
Time Frame
first 4 days of life
Secondary Outcome Measure Information:
Title
Right ventricular function using conventional echocardiography
Description
TAPSE (tricuspid annular plane systolic excursion) in mm .
Time Frame
first 4 days of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Evidence of perinatal/intrapartum hypoxia, as indicated by at least one of: Apgar score of less than or equal to 5 at 10 minutes Needing mechanical ventilation or ongoing resuscitation at 10 minutes PH in cord blood gas is less than 7.00 or a base excess worse than or equal to minus 12 mmol /L on cord/arterial/venous/capillary blood gas obtained within 60 minutes of birth. Evidence of moderate or severe encephalopathy. Greater than or equal to 35 weeks gestational age. Birth weight greater than or equal to 1800 g. Able to begin cooling before 6 hours of birth. Exclusion Criteria: Congenital cyanotic heart disease. Multiple congenital anomalies. Birth asphyxia's babies after start of cooling with cardiovascular instability.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reham M Wagdy, PhD
Organizational Affiliation
Faculty of medicine, Alexandria University, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hossam M Kamel, MBChB
Organizational Affiliation
Faculty of medicine, Alexandria University, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rasha M Adel Nasra
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marwa Mohamed Farag
City
Alexandria
ZIP/Postal Code
0356
Country
Egypt

12. IPD Sharing Statement

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Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates

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