使用氧气对婴儿尿布皮炎的影响
2023年9月20日 更新者：Elif Dogan、Istanbul University - Cerrahpasa (IUC)
背景：让尿布区域通风对皮炎有积极作用。 此外，据文献报道，氧气对伤口护理有效。 我们研究的目的是调查氧气对婴儿尿布皮炎的影响。
方法：由婴儿组成的研究人群将于 2022 年 5 月至 2022 年 9 月入住伊斯坦布尔一家公立医院的新生儿重症监护室。 将 60 名符合研究标准的新生儿随机分为实验组 (n=30) 和对照组 (n=30) 两个。 将使用个人数据表和尿布皮炎观察表来获取数据。 所有婴儿的尿布每天更换 8 次。 每次更换尿布后，将向实验组通氧一小时。 每 24 小时评估一次尿布皮炎的程度。
研究概览
研究类型
介入性
注册 (实际的)
103
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
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-
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Istanbul、火鸡
- Istanbul University Cerrahpasa
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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
1年 至 1年 (孩子)
接受健康志愿者
是的
描述
纳入标准：
- 经家人批准学习
- 出生于 34-42 岁之间。 孕周
- 没有尿布皮炎以外的皮肤病
- 腺体区除皮炎相关病变外无其他疾病的皮损
- 生命体征稳定的新生儿
排除标准：
- 患有尿布皮炎以外的皮肤病
- 由于另一种疾病导致皮肤损伤
- 有已知的皮肤过敏
- 34岁前出生。 孕周
- 患有肠胃疾病
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 |
|---|---|
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实验性的：氧组
婴儿换尿布后，放置在尿布内部的氧气软管将为尿布区域提供自由氧气流。 每次更换尿布时，将以 5 升/分钟的流速和相当于室内空气的 21% FiO2 的浓度应用氧气 1 小时。 |
更换尿布后，将在尿布内放置氧气套管，为尿布区域提供自由流动氧气 1 小时（氧气流量为 %21 Fio2，5 升/分钟）
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无干预：控制组
该组将仅接受常规护理：将使用一次性湿巾和一次性婴儿尿布更换尿布。 将含有 40% 氧化锌的隔离霜薄薄地涂在清洁过的尿布区域，以覆盖皮肤。 宝宝的尿布每天更换 8 次，每三个小时一次。 |
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 |
|---|---|---|
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尿布皮炎愈合量表结果
大体时间：72小时
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期望在干预时治愈尿布皮炎症状。
量表最大值：6，最小值：0。随着量表得分的增加，皮炎的严重程度增加。
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72小时
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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：Elif Dogan、Researcher Assistant
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。
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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)
2022年10月15日
初级完成 (实际的)
2023年3月15日
研究完成 (实际的)
2023年4月15日
研究注册日期
首次提交
2022年6月14日
首先提交符合 QC 标准的
2022年6月16日
首次发布 (实际的)
2022年6月22日
研究记录更新
最后更新发布 (实际的)
2023年9月21日
上次提交的符合 QC 标准的更新
2023年9月20日
最后验证
2023年9月1日
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.