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临床试验/NCT02798926
NCT02798926已完成不适用

Polyethylene Bag: a Way of Preventing Hypothermia During Central Venous Catheter Placement in Preterm Neonates?

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2014年6月19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
63
试验地点
2
主要终点
Temperature

研究概览

简要总结

Particular attention is paid to thermal management of preterm neonates in neonatal intensive care units because of the major risk of morbidity associated with hypothermia. Percutaneous central venous catheter placement is essential to ensure adequate caloric intake and intravenous administration of treatments, but this procedure can cause major body temperature variations, responsible for complications in these neonates, as convection incubator function is impaired during opening of the incubator, which can be prolonged (30 minutes to 2 hours) depending on the technical difficulties encountered during catheter placement.

In parallel, the use of a polyethylene bag or sheet in the delivery room and for neonatal transport is now clearly defined and ensures stability or even a considerable temperature gain during transfer immediately after birth. In the light of several clinical cases, the use of a polyethylene bag during central venous catheter placement appears to be effective to prevent body temperature loss in preterm neonates. No data are currently available concerning the value of this method of prevention of hypothermia during this type of procedure.

Preliminary studies conducted by our team on a dummy suggest that a polyethylene bag or sheet could be useful during this procedure by significantly reducing heat loss caused by convection and evaporation. However, compensation phenomena such as generalized vasoconstriction to cold in preterm infants are very poorly described, but can induce a functional conflict between mechanisms ensuring maintenance of homeostasis and those involved in maintenance of blood pressure.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
0 Days 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • premature Newborn child = 32 weeks of gestational age
  • 7 days of life
  • Normothermic (core temperature between 36.5 and 37.5 ° C)
  • Stable on a hemodynamically manner
  • Need the installation of a central catheter KTEC

排除标准

  • Parental Refusal
  • hypothermia (temperature < 36.5 ° C)
  • Hyperthermia (temperature > 37.5 ° C)
  • heart disease and malformation syndromes life-threatening
  • Hemodynamic instability ( catecholamine vasoconstrictor and vasodilator )
  • Breakdown by oscillation

结局指标

主要结局

Temperature

时间窗: 1 hour

difference between the prehepatic temperature at the beginning of catheter placement and the lowest temperature observed during the procedure

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 (2)

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