Hemodynamic Changes With Heated, Humidified High Flow Nasal Cannula (HHHFNC) Versus Nasal Continuous Positive Airway Pressure (nCPAP) for Respiratory Support of Preterm Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Echocardiography study for preterm neonates among the two study groups while on and off non invasive ventilation.
研究概览
简要总结
This work is designed to:
- Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates.
- Investigate hemodynamic changes associated with HHHFNC in comparison to nCPAP in preterm neonates during periods of non-invasive respiratory support and after being off support.
详细描述
There is a preference of using noninvasive modes of ventilation for management of respiratory distress syndrome (RDS) in preterm infants and of weaning of ventilated neonates as soon as possible to non-invasive modes.
Yet, little is known about which non-invasive mode is better and the hemodynamic changes that occur to the infants secondary to these modes. The study provides an evaluation of the efficacy of heated, humidified high flow nasal cannula (HHHFNC) in comparison to nasal continuous positive airway pressure (nCPAP) in preterm infants. Secondary aim is to assess echographic, cerebral blood flow and mesenteric blood flow changes during HHHFNC versus nCPAP.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants are eligible if they meet the following criteria:
- •Gestational age ≤ 35 weeks.
- •Preterm neonates in need for non invasive ventilation whether they were on invasive ventilatory support before or not.
排除标准
- •Preterm neonates with evidence of any of the following will be excluded:
- •Major upper or lower airway anomalies.
- •Significant congenital anomalies including cardiac, abdominal or respiratory.
- •Hemodynamically significant patent ductus arteriosus (PDA): diagnosed if there is colour doppler echocardiographic evidence of left to right ductal shunt, ductal diameter >1.5mm/kg or left atrial/aortic root ratio >1.4
结局指标
主要结局
Echocardiography study for preterm neonates among the two study groups while on and off non invasive ventilation.
时间窗: 2 years
Done using Bedside functional echocardiography to record Superior vena caval flow (ml/kg/min), right ventricular output flow (ml/kg/min) and left ventricular output flow (ml/kg/min) for each preterm neonate in one of the two study groups (using either HHHFNC and nCPAP) on and off respiratory support.
次要结局
- Anterior cerebral artery Doppler (measuring resistive index) and preprandial Superior mesenteric artery Doppler (measuring resistive index).(2 years)
- Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates.(2 years)
- Preprandial Superior mesenteric artery Doppler measuring superior mesenteric artery blood flow(mL/sec)(2 years)
研究者
Rania Ali El-Farrash
Professor
Ain Shams University