Does Postural Support During Echocardiography Modify Hemodynamic Features and Discomfort Induced by the Examination in Very Premature Neonates?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- value of the ratio of the acceleration time of pulmonary arterial flow.
研究概览
简要总结
Experimental nociceptive stimulation of the fetus and neonate induces pulmonary artery vasoconstriction. The investigators assessed whether echocardiography for Ductus arteriosus screening may generate this hemodynamic response and whether postural support would be able to modulate it.
Study design
Prospective, single center, randomized study in less than 29 weeks of gestation neonates, with a post natal age < 48 hours, and requiring invasive mechanical ventilation.
Crossover design with order of echocardiographies determined by computer randomization: in one group ultrasounds are performed with postural support, than standard conditions, in the other, ultrasounds are performed in standard conditions than with postural support.
The objective of the study is to assess the ratio of the acceleration time/ejection time of pulmonary arterial flow.
The others objectives are to assess echocardiographic-Doppler features (ductus arteriosus shunt pattern, pulmonary flow pattern, estimated systolic pulmonary arterial pressure, right and left ventricular functions using tissue Doppler imaging and speckle-tracking echocardiography), pain assessment with a clinical scale and heart rate variability analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn than 30 weeks of gestation neonates,
- •Newborn with a post natal age < 48 hours,
- •Newborn requiring invasive mechanical ventilation.
- •Signed consent form of parent
排除标准
- 未提供
研究组 & 干预措施
echocardiography with standard condition then support postural
the first echocardiography (ultrasounds) is performed with standard condition (usual) and the second echocardiography is performed with a postural support
干预措施: echocardiography with postural support (Procedure)
echocardiography with standard condition then support postural
the first echocardiography (ultrasounds) is performed with standard condition (usual) and the second echocardiography is performed with a postural support
干预措施: echocardiography with standard condition (usual) (Procedure)
echocardiography with postural support then standard condition
the first echocardiography (ultrasound) is performed with a postural support then the second echocardiography is performed with standard condition
干预措施: echocardiography with standard condition (usual) (Procedure)
echocardiography with postural support then standard condition
the first echocardiography (ultrasound) is performed with a postural support then the second echocardiography is performed with standard condition
干预措施: echocardiography with postural support (Procedure)
结局指标
主要结局
value of the ratio of the acceleration time of pulmonary arterial flow.
时间窗: up to 1 hour
for each echocardiography (support condition and postural support)
value of the ejection time of pulmonary arterial flow
时间窗: up to 1 hour
for each echocardiography (support condition and postural support)
次要结局
- number of participant with a Patent ductus arteriosus shunt(up to 2 hours)
- pain assessment with a clinical scale(up to 1 hour)
- systolic pulmonary arterial pressure(up to 2 hour)