Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part III
2019年2月18日 更新者:Wally Carlo、University of Alabama at Birmingham
Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part III
The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone.
Part III is for preterm/low birth weight infants with or without a plastic torso wrap during the first hour after birth to assist with temperature regulation during placement in an incubator.
研究概览
详细说明
Incubators in the developing world often lack humidifiers.
The resting dry heat increases evaporative heat loss, the most prominent form of heat loss in premature infants due to their increased body surface area and immature stratum corneum.
By potentially increasing humidity around the infants and decreasing evaporative heat losses, plastic bags may improve incubator warming.
This study will compare the incidence of hypothermia in infants placed in an incubator for at least one hour randomized to receive standard incubator protocol (control group) or standard incubator protocol plus a plastic bag covering their torsos and lower extremities (intervention group).
The axillary temperature of each infant will be taken before placement into the incubator and one hour later when the bag will be removed.
Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage, incubator temperature, and humidity, and length of time in an incubator will be recorded throughout the hospitalization for all infants.
With an estimated baseline hypothermia rate of 90% and a hypothesized 20% absolute risk reduction (22% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.
研究类型
介入性
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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Lusaka、赞比亚
- University Teaching Hospital
-
-
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分钟 至 3天 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Infant admitted to the NICU
- Current weight between 1,000 and 2,500g
- Being placed in an incubator
Exclusion Criteria:
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
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:预防
- 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 |
---|---|
假比较器:Incubator-no plastic bag
Placement into an incubator without a plastic bag
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Infant will be placed in the incubator, wrapped in a blanket, with a cloth hat, according to standard protocol.
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有源比较器:Incubator-torso bag
Placement into a plastic bag inside incubator
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While being placed into an incubator, infant will be placed into a plastic bag to his/her axillae and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth.
The infant will be wrapped in a blanket over the plastic bag and will receive a cloth hat.
He/she will remain in the bag for one hour.
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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 |
---|---|---|
Axillary temperature 36.5-37.5 degrees Celsius
大体时间:1-72 hours
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Temperature taken per axilla for 1 minute
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1-72 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
发作
大体时间:长达 4 周
|
由医生或护士诊断的癫痫发作活动。
不会做脑电图。
|
长达 4 周
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气胸
大体时间:长达 4 周
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胸片记录或与漏气一致的临床恶化
|
长达 4 周
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败血症
大体时间:长达 4 周
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培养证实或培养阴性的临床治疗过程与脓毒症一致
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长达 4 周
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死亡
大体时间:长达 4 周
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心肺衰竭
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长达 4 周
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热疗
大体时间:长达 4 周
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腋温 > 38 摄氏度 每腋窝测量一分钟
|
长达 4 周
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Blood glucose
大体时间:Up to 4 weeks
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Measure of blood glucose per laboratory value taken per heel stick
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Up to 4 weeks
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Weight gain
大体时间:Up to 4 weeks
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Infant will be weighed daily and rates of weight gain will be calculated
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Up to 4 weeks
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Major brain injury
大体时间:Up to 4 weeks
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Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound
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Up to 4 weeks
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Pulmonary hemorrhage
大体时间:Up to 4 weeks
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Blood seen in the endotracheal tube and treated by physician
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Up to 4 weeks
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Blood Pressure
大体时间:Up to 4 weeks
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Measure of extremity blood pressure per cuff taken during nursery stay
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Up to 4 weeks
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Respiratory Distress Syndrome (RDS) Respiratory Distress Syndrome (RDS)
大体时间:Up to 4 weeks
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Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant
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Up to 4 weeks
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Bronchopulmonary dysplasia (BPD)
大体时间:28 days after birth
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Oxygen requirement at 28 days after birth
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28 days after birth
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Necrotizing enterocolitis or intestinal perforation
大体时间:Up to 4 weeks
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Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocoliities per Bell's Classification stage greater than 1.
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Up to 4 weeks
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Length of time in Incubator
大体时间:Up to 4 weeks
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Documentation of length of time spent in incubator and number of times placed in incubator
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Up to 4 weeks
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Temperature and humidity
大体时间:1 hour
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A recording of the air temperature and humidity within the incubator will be obtained with each axillary temperature measurement
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1 hour
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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。
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 (预期的)
2012年6月1日
初级完成 (预期的)
2018年10月1日
研究完成 (预期的)
2019年10月1日
研究注册日期
首次提交
2012年5月21日
首先提交符合 QC 标准的
2012年5月21日
首次发布 (估计)
2012年5月23日
研究记录更新
最后更新发布 (实际的)
2019年2月20日
上次提交的符合 QC 标准的更新
2019年2月18日
最后验证
2019年2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.