此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Study of the Effects of CPAP and HHHFNC on Diaphragmatic Dimensions in Preterm Infants

2017年3月9日 更新者：Hesham Abdel-Hady、Mansoura University Children Hospital

Comparative Study of the Effects of Continuous Positive Airway Pressure and Heated, Humidified High Flow Nasal Cannula on Diaphragmatic Dimensions in Preterm Infants

This is a prospective, randomized crossover study to recognize the effects of nasal continuous positive airway pressure (CPAP) versus heated humidified high flow nasal cannula (HHHFNC) on diaphragmatic dimensions and excursion (evaluated by ultrasonography) in preterm infants.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Preterm infants will be recruited consecutively from NICU of Mansoura University Children's Hospital. They will be randomized in two groups; one group will start on nasal CPAP (Fisher & Paykel Healthcare, Auckland, New Z ealand) (Pressure 5 cmH2O) for 60 minutes and then will be switched to HHHFNC (Fisher & Paykel Healthcare, Auckland, New Z ealand) (flow of 4 l/m) for another 60 minutes. The other group will start on HHHFNC and then switched to nasal CPAP.

After the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team.

Ultrasonographic assessment of diaphragmatic dimensions and excursion will be analyzed in different respiratory cycles and the average of 3 cycles will be calculated at the end of the 60 minutes periods on nasal CPAP and HHHFNC.

研究类型

介入性

注册 (实际的)

24

阶段

  • 不适用

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

  • 埃及
    • Dakahlia
      • Mansoura、Dakahlia、埃及、35516
        • Neonatal Intensive Care Unit, Mansoura University Children Hospital
      • Mansoura、Dakahlia、埃及、35516
        • NICU, Mansoura University Children's Hospital

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

不超过 1个月 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Preterm infants < 37 weeks.
  • Stable on nasal continuous positive airway pressure (CPAP) for at least 24 hours.
  • On less than 35% oxygen.

Exclusion Criteria:

  • Congenital and acquired problems of the gastrointestinal tract as necrotizing enterocolitis, esophageal perforation and tracheoesophageal fistula.
  • Phrenic nerve injury and/or diaphragm paralysis
  • 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.
  • 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

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：CPAP first
Infant will be given nasal CPAP for 60 minutes and then put on HHHFNC for another 60 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of the 60 minute periods on nasal CPAP and HHHFNC. After the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team
设备：CPAP first (Fisher & Paykel Healthcare)
Infants will start on nasal CPAP for 60 minutes and then switched to HHHFNC for anther 60 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of each 60 minute epochs.
有源比较器：HHHFNC first
Infant will be given HHHFNC for 60 minutes and then switched to nasal CPAP for another 30 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of the 60 minute periods on HHHFNC and nasal CPAP. After the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team
设备：HHHFNC first (Fisher & Paykel Healthcare)
Infants will start on HHHFNC for 60 minutes and then switched to nasal CPAP for anther 60 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of each 60 minute epochs.

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
Diaphragmatic dimensions (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness)
大体时间：at the end of each 60 minutes epoch on nasal CPAP
Ultrasonographic assessment of (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness will be assessed at the end of each 60 minutes epoch on nasal CPAP. Diaphragm thickness will be measured as the perpendicular distance between the pleural and peritoneal reflections. All measurements will be performed during quiet breathing. Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
at the end of each 60 minutes epoch on nasal CPAP
Right and left diaphragmatic excursion
大体时间：at the end of each 60 minute epoch on CPAP
Ultrasonographic assessment of right and left diaphragmatic excursion will be assessed at the end of each 60 minutes epoch on nasal CPAP. The displacements of the liver and spleen will be monitored in real-time. Using M-mode ultrasonography, with the probe fixed on the chest wall during respiration, ultrasonographic image of will be frozen and a mark for measurement will be placed on the image at the location of the most caudal margin of the liver or spleen at the end of expiration, and a second mark will be placed on the new location of the most caudal margin of the liver or spleen at the end of inspiration. The distance between the two marks will be then measured and defined as the displacement of the liver or the spleen (right or left diaphragmatic excursion). Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
at the end of each 60 minute epoch on CPAP
Diaphragmatic dimensions (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness)
大体时间：at the end of each 60 minutes epochs on HHHNC
Ultrasonographic assessment of (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness will be assessed at the end of each 60 minutes epoch on HHHFNC. Diaphragm thickness will be measured as the perpendicular distance between the pleural and peritoneal reflections. All measurements will be performed during quiet breathing. Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
at the end of each 60 minutes epochs on HHHNC
Right and left diaphragmatic excursion
大体时间：at the end of each 60 minutes epochs on HHHNC
Ultrasonographic assessment of right and left diaphragmatic excursion will be assessed at the end of each 60 minutes epoch on HHHFNC. The displacements of the liver and spleen will be monitored in real-time. Using M-mode ultrasonography, with the probe fixed on the chest wall during respiration, ultrasonographic image of will be frozen and a mark for measurement will be placed on the image at the location of the most caudal margin of the liver or spleen at the end of expiration, and a second mark will be placed on the new location of the most caudal margin of the liver or spleen at the end of inspiration. The distance between the two marks will be then measured and defined as the displacement of the liver or the spleen (right or left diaphragmatic excursion). Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
at the end of each 60 minutes epochs on HHHNC

次要结果测量

结果测量
措施说明
大体时间
Respiratory rate
大体时间：At the end of each 60 minutes epochs on CPAP and HHHFNC
Respiratory rate will be assessed at the end of each 60 minutes epoch on CPAP or HHHFNC
At the end of each 60 minutes epochs on CPAP and HHHFNC
Heart rate
大体时间：At the end of each 60 minutes epochs on CPAP and HHHFNC
Heart rate will be assessed at the end of each 60 minutes epoch on CPAP or HHHFNC
At the end of each 60 minutes epochs on CPAP and HHHFNC
Spo2
大体时间：At the end of each 60 minutes epochs on CPAP and HHHFNC
Oxygen saturation by pulse oximetry (SpO2) will be assessed at the end of each 60 minutes epoch on CPAP or HHHFNC
At the end of each 60 minutes epochs on CPAP and HHHFNC
Number of apneas
大体时间：during the 60 minutes epochs on CPAP and HHHFNC
Number of apneas will be recorded during the 60 minutes epoch on CPAP or HHHFNC
during the 60 minutes epochs on CPAP and HHHFNC

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。

赞助

Mansoura University Children Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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 (实际的)

2015年5月1日

初级完成 (实际的)

2016年10月1日

研究完成 (实际的)

2016年10月1日

研究注册日期

首次提交

2015年4月13日

首先提交符合 QC 标准的

2015年4月17日

首次发布 (估计)

2015年4月20日

研究记录更新

最后更新发布 (实际的)

2017年3月13日

上次提交的符合 QC 标准的更新

2017年3月9日

最后验证

2017年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • MS 874

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.

订阅