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Impact of Different Modes of Noninvasive Ventilation on Regional Oximetry and Hemodynamics in Premature Newborn

2015年8月3日 更新者:Dr. Yaser Ali、University of Manitoba

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

The purpose of this study is to examine the blood flow and the delivery of oxygen to the brain and gut in preterm babies while they are supported with two modes of breathing machine and compare these two methods to see if one allows for better blood flow to the brain and gut.

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

观察性的

注册 (实际的)

10

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Manitoba
      • Winnipeg、Manitoba、加拿大、R2H 2A6
        • St. Boniface General Hospital
      • Winnipeg、Manitoba、加拿大、R3A 1S1
        • Health Sciences Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

2天 至 2个月 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Newborn infants less than 34 weeks gestational age at birth Requiring CPAP or TrPA as a mode of respiratory support

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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.

Measurement of:

  • Left ventricular output (LVO).
  • Right ventricular output (RVO).
  • Assessment of the Mesenteric Artery Flow.
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:
  • 近红外光谱

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
Change in cardiac output
大体时间:Day 3 of life till 2 months of age

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:

  1. Subcostal.
  2. Apical.
  3. Long and short axis parasternal.
  4. Suprasternal

Measurements:

  • Left ventricular output (LVO).
  • Right ventricular output (RVO).
Day 3 of life till 2 months of age
Changes in Superior Mesenteric Artery and Middle Cerebral Artery Doppler flow.
大体时间:Day 3 of life till 2 months of age
Day 3 of life till 2 months of age
Cerebral and mesenteric regional tissue oxygenation
大体时间:Day 3 of life till 2 months of age
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.
Day 3 of life till 2 months of age

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年8月1日

初级完成 (实际的)

2014年8月1日

研究完成 (实际的)

2014年8月1日

研究注册日期

首次提交

2013年7月19日

首先提交符合 QC 标准的

2013年9月10日

首次发布 (估计)

2013年9月16日

研究记录更新

最后更新发布 (估计)

2015年8月4日

上次提交的符合 QC 标准的更新

2015年8月3日

最后验证

2015年8月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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