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Effect of Continuous Positive Airway Pressure Delivered by Two Different Modalities on Breathing Pattern in Preterm Infants

2015年6月16日 更新者:Sunnybrook Health Sciences Centre

Effects of Continuous Positive Airway Pressure (CPAP) Delivered by High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure on the Diaphragm Electrical Activity in Very Low Birth Weight Preterm Infants

In this study, the investigators want to observe how continuous positive airway pressure delivered by two different modalities affects breathing pattern in small preterm infants. Using a specialized feeding tube in the stomach, the investigators can measure and compare how the diaphragm (a large breathing muscle) might be affected by those two modalities.

研究概览

地位

完全的

详细说明

Many preterm very low birth weight infants require continuous positive airway pressure(CPAP) for breathing support because of lung immaturity. CPAP can be delivered by the infant flow(TM) device which is well studied. Prolonged use of nasal prongs CPAP has been shown to cause discomfort and, rarely, nasal injury leading to long term disfigurement. On the other hand, High flow nasal cannula (HFNC) ,which is another modality of delivering CPAP, creates less pressure on the nose and less disfiguring effect but previous research showed that the use of HFNC may be less effective than IF-CPAP in providing breathing support in these infants.

We plan to study 10 stable preterm infants born less than 32 weeks' gestation and 1.5 kilograms at birth after being stable for at least 48hours on IF-CPAP. babies will be randomized to start on IF-CPAP or HFNC for 30 minutes. After 45 minutes of adaptation, baby will be switched to the other modality for another 30 minutes. By inserting a specialized feeding tube with sensors into the stomach, we can measure the electrical activity of the diaphragm (EAdi). By analysing EAdi with each modality of delivering CPAP, we want to directly assess how HFNC affects breathing compared to IF-CPAP.

研究类型

观察性的

注册 (预期的)

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

    • Ontario
      • Toronto、Ontario、加拿大
        • Sunnybrook Health Sciences Centre

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 1年 (孩子)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

clinically stable preterm infants with birth weight less than 1.5 kilograms and gestational age less than 32 weeks admitted to the neonatal intensive care unit at Sunnybrook Health Sciences centre on nasal continuos positive airway pressure(CPAP) of 5-6 cmH2O support for at least 48 hours, treated with Methylxanthines for apnea of prematurity and in less than 35% oxygen.

描述

Inclusion Criteria:

  • Birth weights ≤ 1500g
  • Gestational age less than 32 week
  • Stable on nasal continuous positive airway pressure (CPAP) of 5-6cmH20 support for at least 48 hours
  • Treated with methylxanthines for apnea of prematurity
  • In less than 35% oxygen

Exclusion Criteria:

  • Congenital and acquired problem of the gastrointestinal tract
  • Phrenic nerve injury and/or diaphragm paralysis
  • Esophageal perforation/tracheoesophageal fistula
  • Congenital/acquired neurological deficit and/or seizures
  • Hemodynamic instability
  • Congenital heart disease (including symptomatic patent ductus arteriosus)
  • Undergoing treatment for sepsis or pneumonia
  • Use of muscle relaxants, narcotic analgesics, or gastric motility agents
  • Congenital anomalies of respiratory tract (e.g. CCAM)
  • Infants requiring more than 35% oxygen
  • Infants with facial anomalies
  • Infants with pneumothorax and/or pneumomediatinum
  • Infants in the immediate postoperative period
  • Infants with significant gastric residues and vomiting

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
EAdi 1
babies in this group will first receive CPAP through IF-CPAP for 30 minutes. After another 45 minutes, they will be switched to HFNC for 30 minutes. EAdi will be recorded for the last 15 minutes of each 30 minutes period.
EAdi 2
babies in this group will first receive CPAP through HFNC for 30 minutes. After another 45 minutes, they will be switched to IF-CPAP for 30 minutes. EAdi will be recorded for the last 15 minutes of each 30 minutes period.

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
The difference in the tonic EAdi between IF-CPAP and HFNC .
大体时间:During the 4-hour study period.
Patients will be randomized in two groups, one group will start on IF-CPAP for 30 minutes. After another 45 minutes, this group will be switched to HFNC for another 30 minutes. The other group will start on HFNC and then switched to IF-CPAP. EAdi will be analyzed in the last 15 minutes of each 30 minutes period.
During the 4-hour study period.

次要结果测量

结果测量
措施说明
大体时间
Difference in the number of apnea episodes (breathing pauses) on EAdi recorded with each modality.
大体时间:During the 4-hour study period.
During the 4-hour study period.
Difference in episodes of clinically significant apnea with HFNC and IF-CPAP.
大体时间:During the 4-hour study period.
During the 4-hour study period.
Indices of respiratory muscle effort (inspiratory and expiratory) will be calculated from Edi waveform.
大体时间:During the 4-hour study period.
These indices include the phasic Edi to the peak, mean inspiratory Edi, Edi-time product, post inspiratory activity and all neural timings.
During the 4-hour study period.

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

  • 首席研究员:Michael Dunn, MD、Sunnybrook Health Sciences Centre
  • 首席研究员:Nehad Nasef, M.B.B.Ch、Sunnybrook Health Sciences Centre
  • 首席研究员:Maureen Reilly, RRT、Sunnybrook Health Sciences Centre
  • 首席研究员:Patti Schurr, RN(EC)、Sunnybrook Health Sciences Centre
  • 首席研究员:Jennifer Beck, Ph.D.、Unity Health Toronto
  • 研究主任:Eugene Ng, MD、Sunnybrook Health Sciences Centre

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

2011年5月1日

初级完成 (实际的)

2012年11月1日

研究完成 (实际的)

2012年12月1日

研究注册日期

首次提交

2011年3月23日

首先提交符合 QC 标准的

2011年3月30日

首次发布 (估计)

2011年3月31日

研究记录更新

最后更新发布 (估计)

2015年6月18日

上次提交的符合 QC 标准的更新

2015年6月16日

最后验证

2015年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 254-2010

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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