Can Kangarooing Small Babies on the Back of a Mother Keep Them Warm and Stable
2020年4月14日 更新者：SISAY GERE
The Effect of Chest-to-Back Skin-to-Skin Contact on Regulation of Physiological Parameters for Low Birth Weight and/or Premature Infants: a Crossover Randomized Controlled Clinical Trial
The purpose of this study was to assess the effectiveness of Kangarooing small babies on the back of a mother
研究概览
详细说明
After the study was explained (risks and benefits) and written informed consent was received from participants, an individually controlled randomized crossover clinical trial was conducted to examine the effectiveness of Chest-to-Back (CB) skin-to-skin contact (SSC) compared with the standard.
The trial was done in accordance with the protocol, good clinical practice, and the national regulatory and ethics guideline of Ethiopia (which is in line with the Helsinki declaration).
研究类型
介入性
注册 (实际的)
50
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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Addis Ababa、埃塞俄比亚
- Adds Continental Institute of Public Health
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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天 至 4周 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Neonates with LBW (<2500 grams)
- Born prematurely (< 37 complete weeks of gestation)
Exclusion Criteria:
- less than 35 weeks of gestation on the day of enrollment to trial
- Malformations or birth disabilities
- Dependent on oxygen or IV fluid
- Any disorder that was deemed necessary for exclusion by the investigator.
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：交叉作业
- 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：CB-SSC
The participant received CB-SSC for 2 hours per day for three consecutive days
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其他名称：
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安慰剂比较：CC-SSC
Following a 30 minute washout time, the same participant would continue to receive chest-to-chest (CC) SSC for 2 hours.
This was also conducted for three consecutive days
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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 |
|---|---|---|
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Change in skin temperature from baseline
大体时间：: From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days
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Skin temperature values were recorded every 10 minutes.
Including the baseline, the 2 hours intervention would provide 13 measurements.
A participant who successfully completed the intervention would have78 measurements; 39 for the treatment arm and 39 for the control arm.
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: From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline in peripheral arterial oxygen saturation on SCRIP Score
大体时间：From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days
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Stability of the cardio-respiratory system in premature infants (SCRIP) score is a reliable instrument for determining the stability of oxygen saturation (i.e., peripheral arterial oxygen saturation) in premature infants.
Possible scores range from 2 (perfect stability= > 90 %) to 0 (sever instability = any falls below 80%)
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From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days
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Change from baseline in heart rate on SCRIP Score
大体时间：From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days
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Possible scores range from 2 (perfect stability= regular) to 0 (sever instability = < 80/min or>200).
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From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days
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Change from baseline in respiratory rate on SCRIP Score
大体时间：From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days
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Possible scores range from 2 (perfect stability= regular) to 0 (sever instability = Apnea> 10, Tachypnea> 80/min, fussing/agitation
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From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days
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Length of sleep in minute
大体时间：From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days.
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length of sleep was defined by the duration between the time of closed eyes, no crying and no movement to the time that at least one of these 3 indicators is absent
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From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days.
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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。
赞助
调查人员
- 研究主任：Prof. Yemane Berhane、Director
- 学习椅：Prof. Alemayehu Worku、Deputy
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)
2017年1月3日
初级完成 (实际的)
2019年6月18日
研究完成 (实际的)
2019年10月14日
研究注册日期
首次提交
2020年4月11日
首先提交符合 QC 标准的
2020年4月14日
首次发布 (实际的)
2020年4月15日
研究记录更新
最后更新发布 (实际的)
2020年4月16日
上次提交的符合 QC 标准的更新
2020年4月14日
最后验证
2020年4月1日
更多信息
与本研究相关的术语
其他研究编号
- A/CHS/RC/15/16
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Upon a reasonable request, the investigators can offer access to the datasets used and/or analyzed.
This can be available from the PI (principal investigator)
IPD 共享时间框架
Possibly after six months the data will be available.
IPD 共享访问标准
Upon reasonable request!
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
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