Back to resultsPassive 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
About this trial
This is an interventional diagnostic trial for Hypoxic Encephalopathy focused on measuring therapeutic hypothermia, asphyxiated neonates, tissue Doppler
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.
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
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
Learn more about this trial
Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates
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