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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I: (passive cooling group) | Active Comparator |
| |
| Group II: (Blanket roll III cooling group) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passive cooling application | Device | Passive cooling application for asphyxiated neonates and their effect on myocardial function and hemodynamics |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Right ventricular function using conventional echocardiography | TAPSE (tricuspid annular plane systolic excursion) in mm . | first 4 days of life |
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Inclusion Criteria:
Evidence of perinatal/intrapartum hypoxia, as indicated by at least one of:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Reham M Wagdy, PhD | Faculty of medicine, Alexandria University, Egypt | Principal Investigator |
| Hossam M Kamel, MBChB | Faculty of medicine, Alexandria University, Egypt | Principal Investigator |
| Rasha M Adel Nasra | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marwa Mohamed Farag | Alexandria | 0356 | Egypt |
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| ID | Term |
|---|---|
| D002534 | Hypoxia, Brain |
| D001238 | Asphyxia Neonatorum |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000860 | Hypoxia |
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| cooling using Blanket roll III | Device | standard care using Blanket roll III in asphyxiated neonates and their effect on myocardial function and hemodynamics |
|
| D012818 |
| Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001832 | Body Temperature Changes |