基于线索的喂养过渡期早产儿发展方法
基于线索的喂养过渡期早产儿发展方法——探索临床事实,评估干预效果并制定临床指南
在从管饲到经口喂养的过渡过程中,吸吮、吞咽和呼吸的协调对早产儿来说是一个挑战。 在没有其他合并症的情况下有效地管理喂养过渡,不仅可以改善他们的口腔运动和胃肠功能发育,促进他们的经口喂养学习行为,还有助于他们直接母乳喂养,改善母婴依恋,最终缩短住院时间。 然而,目前支持早产儿整个喂养过渡策略的现状并不一致,并且缺乏基于现有证据的指南和监测指标。
该项目提出了一项三年计划,旨在探索现状,研究集束化治疗的有效策略,并进一步制定可在未来实施的新临床指南。 这项研究的第一年将在台北和台南医疗中心的两个新生儿重症监护病房中使用图表审查。 将采用半结构式访谈和问卷调查(DSCS-N)来探索护士对发展护理的知识、态度和技能;以及在新生儿重症监护病房喂养过渡期间照顾早产儿的经验。 此外,还将记录和分析胎龄、体重、灌胃和经口喂养量以及喂养过程中发生的特殊事件。
第二年,分层随机分配和重复测量设计的实验将与喂养过渡护理包一起使用。 将招募 120 名早产儿并分配到实验组或对照组。 受试者将在一个新生儿重症监护病房中通过常规护理方法或喂养过渡方法喂养。 干预措施包括在向经口喂养过渡期间经口刺激和基于提示的喂养。 研究措施将包括喂养期间的物理指标、POFRAS 和 EFS,以评估实施情况并指导进一步制定临床指南。
指南制定的第三年将遵循 Bowker 和国家健康保险局,包括 5 个阶段。 该指南的结果可以提供更好的建议来支持早产儿的口腔发育,提供基于提示的喂养,并帮助他们成功过渡到口腔营养。
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Tainan、台湾、70101
- National Cheng Kung University Hospital
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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
纳入标准:
- 出生不足 33 周的早产儿
- 吸入氧浓度 (FiO2) 小于 30%
- 能否耐受肠内喂养
排除标准:
- 使用呼吸机(无创呼吸机除外)
- 并发症包括缺氧缺血性脑病(HIE)、脑室内出血(IVH)≥Ⅲ级、脑室周围白质软化症(PVL)、坏死性小肠结肠炎(NEC)≥Ⅱ期
- 先天性异常包括染色体异常、先天性消化系统异常、唇腭裂
- 因监护问题或无法得到早产儿父母/监护人的知情同意
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:非随机化
- 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:PIOMI治疗组
早产儿使用早产儿口腔运动干预(PIOMI)进行口腔按摩
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早产儿口腔运动干预 (PIOMI) 是一种口腔运动计划,可提供辅助运动以激活肌肉收缩,并提供抵抗阻力的运动以增强进食所需的口腔区域的力量。
它旨在促进神经结构的成熟,提高它们吸吮和吞咽的能力。
其他名称:
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无干预:常规护理组
早产儿接受新生儿重症监护室(NICU)的常规护理
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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 |
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早产儿的经口喂养准备
大体时间:口腔刺激阶段从第 1 天(基线)到第 7 天的变化
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我们使用早产儿经口喂养准备评估量表 (POFRAS) 来评估早产儿开始经口喂养的准备情况。
该量表由校正胎龄、行为组织(3项)、口腔姿势(2项)、口腔反射(4项)、非营养性吸吮(8项)等5个5个项目共18个项目进行评价。
每项评分从0~2分,评分越高说明早产儿经口喂养准备越好。
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口腔刺激阶段从第 1 天(基线)到第 7 天的变化
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早产儿经口喂养技巧
大体时间:从第 1 天(基线)到提示基础喂养阶段的第 30 天
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使用早产儿早期喂养技能评估 (EFS)。
早产儿早期喂养技能评估(EFS)清单是评估早产儿经口喂养准备情况(喂养前;是/否)、经口喂养技能(喂养时;全部/大部分/部分/无;从不/偶尔/经常)、经口喂养耐受性(喂养后;是/否)和喂养描述符(喂养后)。
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从第 1 天(基线)到提示基础喂养阶段的第 30 天
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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体重变化
大体时间:从第 1 天(基线)到第 200 天的变化。
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以克为单位的体重变化
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从第 1 天(基线)到第 200 天的变化。
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住院天数(天)
大体时间:从第 1 天到第 200 天。
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从入院(出生日)到出院(出院)多少天。
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从第 1 天到第 200 天。
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合作者和调查者
调查人员
- 首席研究员:Mei-Chih Huang、Department of Nursing, College of Medicine, National Cheng-Kung University
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
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
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