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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates: A Randomized Clinical Trial

Conditions
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Hypoxic Encephalopathy, Birth Asphyxia, Neonatal Encephalopathy, Hypothermia, Newborn

Intervention / Treatment
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* Device: Passive cooling application
* Device: cooling using Blanket roll III


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 6 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I: (passive cooling group)<br> | Device: Passive cooling application<br>* Passive cooling application for asphyxiated neonates and their effect on myocardial function and hemodynamics<br>|
| Placebo Comparator: Group II: (Blanket roll III cooling group)<br> | Device: cooling using Blanket roll III<br>* standard care using Blanket roll III in asphyxiated neonates and their effect on myocardial function and hemodynamics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | first 4 days of life | 
| Left ventricular function through using conventional echocardiography. | Ejection fraction in percent . | first 4 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right ventricular function using conventional echocardiography | TAPSE (tricuspid annular plane systolic excursion) in mm . | first 4 days of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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therapeutic hypothermia, asphyxiated neonates, tissue Doppler