Impact of Different Modes of Noninvasive Ventilation on Regional Oximetry and Hemodynamics in Premature Newborn
Impact of Different Modes of Noninvasive Ventilation (NCPAP Versus TrPA) on Regional Cerebral and Splanchnic Oximetry as Measured by Near Infrared Spectroscopy (NIRS) and Hemodynamics Using Echocardiography in Premature Newborns
研究概览
详细说明
Preterm babies under 32 weeks of gestational age usually needs to be supported with breathing machine because of different kinds of problems like lungs immaturity or infection. One type of breathing machine support is called CPAP(Continuous Positive Airway Pressure).This breathing support machine is connected to the nose to help preterm baby breathe. This machine blows air or an air/oxygen mixture through the nose and in to the baby's lung; this helps to keep baby's lungs fully open and makes it easier for the baby to breathe. There are two ways this machine can help the baby breathe - it can either blow the air/oxygen mixture at the same pressure all the time…we call that CPAP, or we can vary the pressure - we call that TrPA(Trigger Pressure Assist). Both methods have been in use in neonatal intensive care units(NICUs) for several years and both methods help with the breathing of babies.
The breathing machine (CPAP) makes the lungs better inflated. This inflation might affect the ability of the heart to push the blood to the organs through the blood vessels. Also we do not know whether there is any difference in the blood flow or oxygen delivery depending whether the baby is on CPAP or TrPA.
We will measure the heart function using Ultrasound (Echocardiography). To measure the efficiency of the flow of the blood through the vessels to the organs we will use Near Infra Red Spectroscopy (NIRS); this involves applying a sensor to the baby's skin - one on the forehead and one on the tummy and connecting the sensors to a machine which can measure the oxygen level in the organ under the skin.
While the baby is on CPAP, we will start monitoring oxygen saturation by applying NIRS sensors to the forehead and the abdomen. After 3 hours we will do echocardiography (ultrasound of the heart)to see any changes that might happen to the heart and blood vessels while the baby is on CPAP. Then, using the same machine, we will change the mode of respiratory support to TrPA. After another three hours, we will do another echocardiography (ultrasound of the heart), then we will stop NIRS monitoring and change the mode of respiratory support back to CPAP.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Manitoba
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Winnipeg、Manitoba、加拿大、R2H 2A6
- St. Boniface General Hospital
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Winnipeg、Manitoba、加拿大、R3A 1S1
- Health Sciences Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Preterm infants less than 34 weeks gestational age
- Requirement of CPAP or TrPA as a mode of respiratory support
Exclusion Criteria:
- Lack of parental consent
- Preterm infants more than 34 gestational weeks
- Preterm infants with congenital malformation
- Severe perinatal asphyxia
- Hemodynamically significant patent ductus arteriosus (PDA)
- Pulmonary hypertension
- Septic shock
- Any associated congenital heart diseases other than non-significant PDA or patent foramen ovale (PFO)
- Stage 2 or 3 necrotising enterocolitis (NEC)
- Intraventricular hemorrhage (IVH) grade 3 or 4
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Preterm ≤ 32 weeks GA, on CPAP
Preterm infants less than 32 weeks gestational age requiring CPAP as a mode of respiratory support and admitted in the NICU.While the baby is on CPAP,tissue oxygen saturation monitoring will be started by applying NIRS(Near Infrared Spectroscopy Monitoring) sensors to the forehead and the abdomen.
After 3 hours,echocardiography(including Superior Mesenteric Artery Doppler) will be done while the baby is on CPAP.
Then, using the same machine, the mode of respiratory support will be changed to TrPA.
After another three hours,another echocardiography will be done,then NIRS monitoring will be stopped and the mode of respiratory support will be changed back to CPAP.
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Measurement of:
Measurement of cerebral and mesenteric regional oxygen saturation(rSO2) trends and data while the baby on CPAP or TrPA modes of noninvasive ventilation.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in cardiac output
大体时间:Day 3 of life till 2 months of age
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Targeted neonatal Echocardiography will be done according to the guidelines accepted by the writing group of the American society of echocardiography in collaboration with associations of European pediatric cardiologists The following standard windows will be used:
Measurements:
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Day 3 of life till 2 months of age
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Changes in Superior Mesenteric Artery and Middle Cerebral Artery Doppler flow.
大体时间:Day 3 of life till 2 months of age
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Day 3 of life till 2 months of age
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Cerebral and mesenteric regional tissue oxygenation
大体时间:Day 3 of life till 2 months of age
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Cerebral and mesenteric rSO2 trends and data (obtained by NIRS) will be recorded along with simultaneous pulse oximeter trends and data.
The splanchnic-cerebral oxygenation ratio (SCOR) reflecting the ratio between regional cerebral oxygen saturation(rcSO2) and regional splanchnic oxygen saturation (rsSO2)(rcSO2/rsSO2) will be analyzed.
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Day 3 of life till 2 months of age
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合作者和调查者
调查人员
- 研究主任:Ganesh Srinivasan, MD、University of Manitoba
- 研究主任:Mary S Seshia, MD、University of Manitoba
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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