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Cardboard Cot: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib

2021年10月22日 更新者:Colm Travers、University of Alabama at Birmingham

Cardboard Cot in Neonatal Thermoregulation: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib

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.

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

介入性

阶段

  • 不适用

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 2周 (孩子)

接受健康志愿者

有资格学习的性别

全部

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

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
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.
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.
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.
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.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
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
Up to 14 days

次要结果测量

结果测量
大体时间
Hypothermia (< 36.0° C) throughout the duration of the intervention measured by axillary temperature
大体时间:Up to14 days
Up to14 days
Mean Axillary Temperatures on All Infants Weaned to Cardboard Cots
大体时间:4 months
4 months
Mean Axillary Temperatures on All Infants Weaned to Open Cribs
大体时间:4 months
4 months
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
1 hour after placement in warming device
Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
大体时间:6 hours
6 hours
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
24 hours after placement in warming device
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
1 hour after placement in warming device
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
6 hours after placement in warming device
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
24 hours after placement in warming device
Rate of Hyperthemia (>38° C) measured by axillary temperature
大体时间:14 days
14 days
Rate of Normothermia (>36.5° C) at discharge measured by axillary temperature
大体时间:Up to 14 days
Up to 14 days

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

  • 首席研究员:Colm P Travers, MB BCh BAO、University of Alabama at Birmingham

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)

2019年6月11日

初级完成 (实际的)

2021年9月27日

研究完成 (实际的)

2021年9月27日

研究注册日期

首次提交

2017年11月14日

首先提交符合 QC 标准的

2017年11月14日

首次发布 (实际的)

2017年11月17日

研究记录更新

最后更新发布 (实际的)

2021年10月26日

上次提交的符合 QC 标准的更新

2021年10月22日

最后验证

2021年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • UAB Neo 019

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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