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临床试验/NCT03648606
NCT03648606已完成不适用

Improvement of the Early Management and Thermal Comfort of Premature Infants Under 32 Weeks of Amenorrhea Placed in a Closed Incubator: Comparison of the Use of the Incubator in Conventional "Air" vs. "Cutaneous" Regulation Mode .

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2010年6月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
Mesure of the Thermal confort of preterm infants less than 32 weeks

研究概览

简要总结

Sleep propensity was assessed in terms of the duration of a spontaneous episode of wakefulness (W). Skin temperatures at six body sites (the abdomen, pectoral region, eye, hand, thigh and foot) were measured (using infrared thermography) during nocturnal polysomnography in 29 9-day-old preterm neonates (postmenstrual age: 209 9 days). Te investigators then determined whether the duration of the W episode depended upon the local skin temperatures measured at the start, during and end of the episode.

详细描述

Although sleep is of paramount importance for preterm neonates, care of the latter in a neonatal intensive care unit does not favour sleep. Given that several studies in adults have described a 'vegetative preparedness to sleep' (in which distal skin vasodilation before lights-out promotes rapid sleep onset), the investigators looked at whether or not this process operates in preterm neonates. Sleep propensity was assessed in terms of the duration of a spontaneous episode of wakefulness (W). Skin temperatures at six body sites (the abdomen, pectoral region, eye, hand, thigh and foot) were measured (using infrared thermography) during nocturnal polysomnography in 29 9-day-old preterm neonates (postmenstrual age: 209 9 days).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
1 Day 至 10 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •premature newborns 25 to 32 weeks of amenorrhea;
  • •arrival in the Neonatal Medicine Unit <12 hours of life;
  • •need for management in a closed incubator;
  • •availability of an incubator equipped with communication card.

排除标准

  • •premature newborns> 32 weeks of amenorrhea;
  • •arrival in the Neonatal Medicine unit after 12 hours of life;
  • •presence of malformation syndrome or serious heart disease;
  • •pathology requiring management within the first 10 days of life;
  • •Apgar score <5 at 10 minutes of life;
  • •need for initial management in an open incubator;
  • •unavailability of an incubator equipped with a communication card

结局指标

主要结局

Mesure of the Thermal confort of preterm infants less than 32 weeks

时间窗: 10 days

The objective of this study is to evaluate the thermal confort (variability of the heart and respiratory frequencies) of preterm infant placed in a clmosed incubator to reduce the thermal stress of the very premature newborn (\< 32 weeks of amenorrhea) during the first 10 days of life.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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