跳至主要内容
临床试验/NCT03919188
NCT03919188招募中不适用

Comparison of Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG Raised in Closed Incubators: Impact on Body Growth and Morbidity

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
164
试验地点
2
主要终点
Change in body weight

研究概览

简要总结

Previous studies have shown that mortality and morbidity in preterm neonates are correlated with the fall in body temperature on admission. Hypothermia can be decreased by reducing body heat losses to the environment. The investigator research hypothesis is that a new calculation of the air temperature in the incubator would promote the newborn infant weight growth from the period between birth and day 10 of life compared to cutaneous mode. The secondary hypotheses assumes a decrease in the side effects usually observed in both morbidity and mortality.

A software is used to calculate the body heat loss (BHL) of each individual preterm infant, and to propose a specific air temperature setting inside the incubator to reduce BHL to zero. This software has been validated in a previous pilot study (Degorre et al. 2015). This study aims to compare the energy costs of providing incubated preterm infants born between 25 and 32 weeks of gestation with homeothermia using either specific individualized air temperature control (ATC) or skin servocontrol (SSC).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
— 至 1 Day(Child)
性别
All
接受健康志愿者

入选标准

  • preterm infant born between 25+0 and 32+0 weeks of gestation
  • preterm infant included in the study before 24 +/- 12 hours of life
  • preterm infant nursed in a closed incubator
  • written informed consent from his parents

排除标准

  • newborn infant with polymalformative syndrome
  • life threatening events or serious heart disease

结局指标

主要结局

Change in body weight

时间窗: until day 10 of life

Change in body weight between birth and day 10 of life

次要结局

  • humidity challenge using TEWL(until day 10 of life)
  • length of hospitalization stay(until age corresponding to 40 weeks of amenorrhea or end of hospitalization)
  • Comfort of the preterm infant(until day 10 of life)
  • thermal stress occurence(until day 10 of life)
  • neonatal morbidity occurence(until age corresponding to 40 weeks of amenorrhea)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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