Cardboard Cot in Neonatal Thermoregulation: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Moderate (32.0-35.9° C) or Severe (<32.0° C) Hypothermia at discharge per axillary Temperature
研究概览
简要总结
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 delivered in a setting where an incubator is not available, will be randomized to either standard protocol of open crib or mylar-lined cardboard cot 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 24 Hours 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Major congenital anomalies
- •Requiring ongoing respiratory support
- •Suspected sepsis
研究组 & 干预措施
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.
干预措施: Cardboard Cot Care (Other)
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.
干预措施: Open Crib (Other)
结局指标
主要结局
Moderate (32.0-35.9° C) or Severe (<32.0° C) Hypothermia at discharge per axillary Temperature
时间窗: Up to 14 days
次要结局
- Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature(24 hours after placement in warming device)
- Mean Axillary Temperatures on All Infants Weaned to Cardboard Cots(4 months)
- Mean Axillary Temperatures on All Infants Weaned to Open Cribs(4 months)
- Hypothermia (< 36.0° C) throughout the duration of the intervention measured by axillary temperature(Up to14 days)
- Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary Temperature(1 hour after placement in warming device)
- Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature(24 hours after placement in warming device)
- Rate of Hyperthemia (>38° C) measured by axillary temperature(14 days)
- Rate of Normothermia (>36.5° C) at discharge measured by axillary temperature(Up to 14 days)
- Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature(6 hours)
- Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature(1 hour after placement in warming device)
- Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature(6 hours after placement in warming device)
研究者
Colm Travers
Principal Investigator
University of Alabama at Birmingham