Treatment Of Bronchiolitis With Heated Humidified High Flow Nasal Cannula - Prospective And Retrospective Research
IMLEMENTATION OF High Flow Nasal Cannulae Therapy FOR THE TREATMENT OF BRONCHIOLITIS IN A GENERAL PEDIATRIC WARD - A RETROSPECTIVE AND PROSPECTIVE CLINICAL TRIAL
研究概览
详细说明
Supportive Care, Single Group Assignment, Open Label, Non-Randomized, Efficacy Study
The research is devised as follows:
Prospective section: We will enroll children 0-2 years old, diagnosed with Bronchiolitis in our ward (Pediatrics C) during the months of November-March 2014-2016. Children will be evaluated according to a Bronchiolitis Severity Score devised by Wang and Co which was successfully used in previous research. Children answering criteria for moderate or severe Bronchiolitis according to Wang and Co. will be enrolled pending written consent by both parents.
Our prediction is to enroll a total of 200 children during the 2 winter seasons during 2014-2016.
Retrospective section: We will examine up to 200 cases of children aged 0-2 years hospitalized due to Bronchiolitis in Pediatrics C during 2014-2016 which were not enrolled in our research (due to lack of consent/unavailable HHHFNC etc.). We will compare clinical data and vital parameters between the groups treated with HHHFNC and those who were not.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Petah Tikva、以色列
- 招聘中
- Schneider Medical Center of Israel
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接触:
- Eran Rom, MD
- 电话号码:+972-54-770-5626
- 邮箱:Eranr2@clalit.org.il
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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:
in age interval, diagnosed with Bronchiolitis
Exclusion Criteria:
Chronic heart/lung disease, immunocompromised state
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:HeatedHumidifiedHighFlowNasalCannula
Treatment for moderate-severe cases of Bronchiolitis while monitoring medical parameters
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We will enroll children 0-2 years old, diagnosed with Bronchiolitis in our ward (Pediatrics C) during the months of November-March 2014-2016. Children will be evaluated according to a Bronchiolitis Severity Score devised by Wang and Co. [3] which was successfully used in previous research. Children answering criteria for moderate or severe Bronchiolitis according to Wang and Co. will be enrolled pending written consent by both parents. Our prediction is to enroll a total of 200 children during the 2 winter seasons during 2014-2016.
其他名称:
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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 |
---|---|---|
Changes in Bronchiolitis Severity Score grade
大体时间:during the 20-40 hours of the protocol
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The grade in the Bronchiolitis Severity Score (0-12) reflects a general improvement or deterioration in any of these 5 parameters - oxygen saturation, breath rate, general appearance, degree of dyspnea and lung auscultation result.
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during the 20-40 hours of the protocol
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
CO2 pressure
大体时间:during the 20-40 hours of the protocol
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(in mmHg) measured by a transcutaneous sensor.
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during the 20-40 hours of the protocol
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Medical interventions
大体时间:during the 20-40 hours of the protocol
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Any medication given to the child during the time of the protocol including IV fluids, inhalations, diuretics.
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during the 20-40 hours of the protocol
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Ability to take in food orally
大体时间:during the 20-40 hours of the protocol
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Whether the child has been able to feed - yes or no.
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during the 20-40 hours of the protocol
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Number of Pediatric Intensive Care Unit (PICU) admissions
大体时间:The whole hospitalization period of the child
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Whether the child needed admission to PICU
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The whole hospitalization period of the child
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合作者和调查者
调查人员
- 首席研究员:Eran Rom, Dr.、Schneider Children Medical Center of Israel
研究记录日期
研究主要日期
学习开始
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 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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