The Impact of Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Myocardial function through using tissue Doppler (TD).
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Hour 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Congenital cyanotic heart disease.
- •Multiple congenital anomalies.
- •Birth asphyxia's babies after start of cooling with cardiovascular instability.
结局指标
主要结局
Myocardial function through using tissue Doppler (TD).
时间窗: first 4 days of life
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.
时间窗: first 4 days of life
Ejection fraction in percent .
次要结局
- Right ventricular function using conventional echocardiography(first 4 days of life)
研究者
Marwa Mohamed Farag
Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine
Alexandria University