Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section (THER5)
2013年5月11日 更新者：PD Dr. Jan Hoecker、University Hospital Schleswig-Holstein
Study That Evaluates the Incidence and Possibilities for Prevention of Hypothermia in Newborns Bonding During Caesarean Section
This study should evaluate whether newborns during cesarean section are endangered to get hypothermic while bonding on the mothers chest.
Therefore, the investigators want to investigate the effects of active cutaneous warming of the mothers and babies during intraoperative bonding. The investigators plan to enroll 40 parturients scheduled for elective caesarean section to receive passive insulation or forced-air skin surface warming. The investigators will measure core temperature of the newborns and their mothers. The investigators hypothesize that newborns became most often hypothermic without active warming during the bonding procedure and that active warming will be able to decrease the number of hypothermic newborns significantly.
研究概览
详细说明
Little is known about the thermoregulatory effects on babies when bonding on the chest of the mother during caesarian section.
The aim of our study is to evaluate whether newborns during cesarean section are endangered to get hypothermic while bonding on the mothers chest.
The investigators want to investigate the effects of active cutaneous warming of the mothers and babies during a 20 min intraoperative bonding period.
The investigators plan to enroll 40 parturients scheduled for elective caesarean section under spinal anaesthesia to receive passive insulation or forced-air skin surface warming.
The investigators will measure core temperature of the newborns and their mothers.
The investigators hypothesize that newborns became most often hypothermic without active warming during the bonding procedure and that active warming will be able to decrease the number of hypothermic newborns significantly.
研究类型
介入性
注册 (实际的)
40
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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Schleswig-Holstein
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Pinneberg、Schleswig-Holstein、德国、25421
- Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management
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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
不超过 20分钟 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- parturients undergoing planned, elective cesarean section under spinal anaesthesia
- mothers classified as American Society of Anaesthesiologists (ASA) status I or II
- written informed consent
Exclusion Criteria:
- mothers younger than 18 years
- mothers classified as American Society of Anaesthesiologists (ASA) status III or higher
- caesarean section planned under general anaesthesia.
any expected problems with the newborn such as:
- gestation date < 36 or > 42 week
- placenta previa, abruption of placenta, green amniotic fluid, amnion infection syndrome or any abnormalities in cardiotocography (CTG)
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：Control; passive insulation
The mothers will receive passive temperature insulation by a cotton blanket (standard procedure) after start of the spinal anaesthesia for cesarean section.
The newborn will be bonded on the mothers chest under the cotton blanket (also passive insulation without active warming) for 20 min after birth (bonding period).
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实验性的：Active Warming
The mothers will receive active warming by a forced-air warming blanket after start of the spinal anaesthesia for cesarean section.
The newborn will be bonded on the mothers chest under the warming blanket for 20 min after birth (bonding period).
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In the intervention group a forced-air cover (Level 1 Snuggle Warm Upper Body Blanket, Smiths Medicals) will be positioned over the upper body of the patients laying on the operating table just beginning after the spinal block.
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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Body core temperature of the newborn
大体时间：20 min after birth
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Core temperature of the infants will be measured with specific probes 20 min after birth (end of bonding period)by a rectal temperature probe.
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20 min after birth
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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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Skin temperature of the newborn
大体时间：20 min after child birth
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Skin temperature of the infants will be measured with specific probes 20 min after birth (end of bonding period) at chest, arm, thigh, and calf.
Mean-skin temperature will be calculated from these measurements.
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20 min after child birth
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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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Shivering incidence of the mothers
大体时间：20 min after child birth
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Shivering of the mothers will be graded by a four-point scale.
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20 min after child birth
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Thermal comfort of the mothers
大体时间：20 min after child birth
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Thermal comfort of the mother will be evaluated with a 100-mm visual analogue scale.
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20 min after child birth
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Mean arterial blood pressure of the mothers.
大体时间：20 min after child birth
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Mean arterial blood pressure of the mothers will be assessed by non-invasive measurement.
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20 min after child birth
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Core temperature of the mothers
大体时间：20 min after child birth
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Core temperature will be measured by a sublingual temperature probe.
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20 min after child birth
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Skin temperature of the mothers.
大体时间：20 min after child birth
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Skin temperature of the mothers will be assessed at the chest.
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20 min after child birth
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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
- 学习椅：Berthold Bein, M.D.、University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
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
2013年2月1日
初级完成 (实际的)
2013年4月1日
研究完成 (实际的)
2013年4月1日
研究注册日期
首次提交
2013年2月12日
首先提交符合 QC 标准的
2013年2月14日
首次发布 (估计)
2013年2月15日
研究记录更新
最后更新发布 (估计)
2013年5月14日
上次提交的符合 QC 标准的更新
2013年5月11日
最后验证
2013年5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.
Forced-air warming的临床试验
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Ann & Robert H Lurie Children's Hospital of Chicago完全的