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Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD

Nasal High-frequency Oscillatory Ventilation (NHFOV) vs Nasal Continuous Positive Airway Pressure(NCPAP) for Ventilated Newborn Infants With BPD: a Randomized Controlled Trial

Invasive ventilation(IV) remains one key cornerstone to reduce neonatal mortality for preterm infants with respiratory distress syndrome(RDS) and/or acute respiratory distress syndrome(ARDS). However, it is also related to increased risks of ventilator-associated lung injury and escalation of pulmonary inflammation, and which finally result in bronchopulmonary dysplasia (BPD). Early weaning from IV in newborn infants with BPD is therefore a key procedure to reduce these risks above.

研究概览

详细说明

Supplying with the combined advantages of NCPAP and high-frequency oscillatory ventilation (HFOV) with high carbon dioxide(CO2) removal, no need for synchronisation, non-invasion, less volume/barotraumas, and increased functional residual capacity, nasal HFOV(NHFOV) was considered as a strengthened version of NCPAP. Furthermore, the superimposed oscillations of NHFOV could avoid gas-trapping, and allowed to obviously up-regulate mean airway pressure (MAP) more than NCPAP. Thus, NHFOV might be more beneficial as post-extubation respiratory support strategy to avoid re-intubation and subsequent complications and/or sequelae as compared with NCPAP in preterm infants. Nowadays, NHFOV was increasingly used in neonatal intensive care unit (NICU) around the world due to its convenient operation. A retrospective review has reported the beneficial effects of NHFOV in preterm infants as a remedial measure after failing to other noninvasive modes, including reducing the number of apneas, bradycardias or oxygen desaturations. However, there were rare randomized controlled studies comparing NHFOV with NCPAP in preterm infants with BPD.

We have found that NHFOV is superior to NCPAP in avoiding re-intubation in very preterm infants with the first extubation. The purpose of the present study was to compare NHFOV with NCPAP as post-extubation respiratory support strategies on the need for endotracheal ventilation, as well as pressure of CO2(PCO2) level in preterm infants with BPD.

研究类型

介入性

注册 (预期的)

200

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。

学习联系方式

  • 姓名:Chen(陈) Long, MD, PhD
  • 电话号码:+8613883559467
  • 邮箱neuroclong@126.com

学习地点

    • Chongqing
      • Chongqing、Chongqing、中国、400014
        • 招聘中
        • Chen(陈)
        • 接触:

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

4周 至 6个月 (孩子)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

Eligibility requirements for neonates:

  • The gestational age is less than 32 weeks
  • The preterm neonates are diagnosed with BPD and need invasive ventilation
  • Extubation and subsequent noninvasive ventilation is ready to be carried out

Exclusion Criteria:

one of the following conditions is needed:

  • there were no intraventricular hemorrhage(IVH) grades 3 or 4
  • major congenital anomalies
  • parents' decision not to participate

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:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:NHFOV
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
有源比较器:NCPAP
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP

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
re-intubation rate
大体时间:seven days after extubation
the newborn infants with ventilated BPD is reintubated after extubation
seven days after extubation
death
大体时间:seven days after extubation
the newborn infants with BPD die
seven days after extubation
the level of carbon dioxide
大体时间:seven days after extubation
the level of carbon dioxide is measure after extubation between groups
seven days after extubation

次要结果测量

结果测量
措施说明
大体时间
necrotizing entercolitis(NEC)
大体时间:seven days after extubation
the newborn infants with BPD is diagnosed with NEC
seven days after extubation
intraventricular hemorrhage(IVH)
大体时间:seven days after extubation
the newborn infants with BPD is diagnosed with NEC
seven days after extubation

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。

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)

2021年5月20日

初级完成 (预期的)

2024年12月31日

研究完成 (预期的)

2024年12月31日

研究注册日期

首次提交

2021年2月26日

首先提交符合 QC 标准的

2021年5月26日

首次发布 (实际的)

2021年5月28日

研究记录更新

最后更新发布 (实际的)

2022年10月14日

上次提交的符合 QC 标准的更新

2022年10月13日

最后验证

2022年10月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

NHFOV的临床试验

3
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