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
研究概览
地位
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
注册 (预期的)
阶段
- 不适用
联系人和位置
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
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Chongqing
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Chongqing、Chongqing、中国、400014
- 招聘中
- Chen(陈)
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接触:
- Chen(陈) Long, MD,PhD
- 电话号码:+8613883559467
- 邮箱:neuroclong@126.com
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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
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
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 |
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实验性的:NHFOV
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
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After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
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有源比较器:NCPAP
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP
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After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP
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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 |
---|---|---|
re-intubation rate
大体时间:seven days after extubation
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the newborn infants with ventilated BPD is reintubated after extubation
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seven days after extubation
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death
大体时间:seven days after extubation
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the newborn infants with BPD die
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seven days after extubation
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the level of carbon dioxide
大体时间:seven days after extubation
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the level of carbon dioxide is measure after extubation between groups
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seven days after extubation
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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
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the newborn infants with BPD is diagnosed with NEC
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seven days after extubation
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intraventricular hemorrhage(IVH)
大体时间:seven days after extubation
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the newborn infants with BPD is diagnosed with NEC
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seven days after extubation
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.
NHFOV的临床试验
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Fondazione Poliambulanza Istituto OspedalieroFondazione Policlinico Universitario Agostino Gemelli IRCCS; Fondazione IRCCS Ca' Granda, Ospedale... 和其他合作者完全的
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Xingwang ZhuUniversity of Southern California; Children's Hospital of Fudan University; The Second Hospital... 和其他合作者完全的
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Jiulongpo No.1 People's Hospital招聘中