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