Cardboard Cot: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
Cardboard Cot in Neonatal Thermoregulation: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
研究概览
详细说明
Following parental consent, preterm infants with an estimated gestational age < 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available, or who are in the newborn ICU in a setting where an incubator is not available, will be randomized to to transfer either standard protocol of open crib or mylar-lined cardboard cot when their temperatures are stable for transfer. The infants will remain in the cot or crib for the duration of the hospital stay. Axillary temperatures will be taken 1 hr, 6 hrs, and 24 hours after being placed in the cot or crib, and then once every 24 hours. All other care is provided as standard of care, including WHO warm chain thermoregulation guidelines of early and exclusive breastfeeding, appropriate bundling and Kangaroo Mother Care as continuously as possible.
If at any point a babies becomes moderately (32.0-35.9° C) or severely hypothermic (< 32.0° C), an extra blanket will be added to their bodies and a hat placed on their heads.
研究类型
阶段
- 不适用
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
Inclusion Criteria:
- Estimated gestational age < 36 6/7 weeks
- Hospitalized in the newborn ICU at University Teaching Hospital
- Nursed in an incubator for at least 24 hours
- Thought to be ready to be weaned from incubator by the clinical staff
Exclusion Criteria:
- Major congenital anomalies
- Requiring ongoing respiratory support
- Suspected sepsis
学习计划
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 |
|---|---|
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有源比较器:Cardboard Cot Care
Stable infant will be transferred to cardboard cot, lined with reflective film for duration of hospital stay following weaning from radiant warmer.
Infant's axillary temperature will be taken at 1 hour, 6 hours, 24 hours after being placed in the cot or crib, and then once every 24 hours until discharge.
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When ready to be weaned from radiant warmer, infant will be placed in a reflective film-lined cot for the duration of hospitalization.
Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after placement in cot, and every 24 hours thereafter until discharge.
If temperatures found < 36.0 at any time, an additional blanket and hat will be added to infant to improve temperature.
All other care will be standard of care at University Teaching Hospital, including early and exclusive breastfeeding, appropriate bundling, and Kangaroo Mother Care as continuously as possible.
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安慰剂比较:Open Crib
Stable infant will be transferred to standard of care open crib for duration of hospital stay following weaning from radiant warmer.
Infant's axillary temperature will be taken at 1 hour, 6 hours, 24 hours after being placed in the cot or crib, and then once every 24 hours until discharge.
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When ready to be weaned from radiant warmer, infant will be placed in a standard of care open crib for the duration of hospitalization.
Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after placement in cot, and every 24 hours thereafter until discharge.
If temperatures found < 36.0 at any time, an additional blanket and hat will be added to infant to improve temperature.
All other care will be standard of care at University Teaching Hospital, including early and exclusive breastfeeding, appropriate bundling, and Kangaroo Mother Care as continuously as possible.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Moderate (32.0-35.9° C) or Severe (<32.0° C) Hypothermia at discharge per axillary Temperature
大体时间:Up to 14 days
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Up to 14 days
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Hypothermia (< 36.0° C) throughout the duration of the intervention measured by axillary temperature
大体时间:Up to14 days
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Up to14 days
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Mean Axillary Temperatures on All Infants Weaned to Cardboard Cots
大体时间:4 months
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4 months
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Mean Axillary Temperatures on All Infants Weaned to Open Cribs
大体时间:4 months
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4 months
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Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary Temperature
大体时间:1 hour after placement in warming device
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1 hour after placement in warming device
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Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
大体时间:6 hours
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6 hours
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Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
大体时间:24 hours after placement in warming device
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24 hours after placement in warming device
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Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
大体时间:1 hour after placement in warming device
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1 hour after placement in warming device
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Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
大体时间:6 hours after placement in warming device
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6 hours after placement in warming device
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Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
大体时间:24 hours after placement in warming device
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24 hours after placement in warming device
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Rate of Hyperthemia (>38° C) measured by axillary temperature
大体时间:14 days
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14 days
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Rate of Normothermia (>36.5° C) at discharge measured by axillary temperature
大体时间:Up to 14 days
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Up to 14 days
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合作者和调查者
调查人员
- 首席研究员:Colm P Travers, MB BCh BAO、University of Alabama at Birmingham
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 (实际的)
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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