Effect of a Servo-control System on Heat Loss in Very Low Birth Weight Infants at Birth: a Multicenter, Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 2
- 主要终点
- Proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission
研究概览
简要总结
Hypothermia in preterm infants during the immediate postnatal phase is associated with morbidity and mortality and remains an unresolved, worldwide challenge.
A list of interventions, including adequate room temperature, use of infant warmers, polyethylene bags/wrap, pre-heated mattresses, caps and heated and humidified gases, to prevent thermal loss at birth in very preterm infants has been recommended, but a certain percentage of very preterm infants are hypothermic at the time of the neonatal intensive care unit (NICU) admission suggesting that further measures are needed. The thermal servo-controlled systems are routinely used in the NICU to accurately manage the patients' temperature, but their role during the immediate postnatal phase has not been previously assessed.
We hypothesized that using a thermal servo-control system at delivery could prevent heat loss during this delicate phase and increase the percentage of very low birth weight infants (VLBWI) in the normal thermal range (temperature 36.5-37.5°C) at NICU admission. The aim of this study will be to compare two modes of thermal management (with and without the use of a thermal servo-controlled system) for preventing heat loss at birth in VLBWI infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Nurses who will measure the temperature at NICU admission are blind to treatment arm in the delivery room
入排标准
- 年龄范围
- 1 Minute 至 1 Minute（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated birth weight <1500 g and/or gestational age <30+6 weeks (and)
- •Inborn (and)
- •Parental consent
排除标准
- •Major congenital malformations (i.e. cardiac disease, defects of abdominal wall, ...);
- •Parental refusal to participate to the study.
结局指标
主要结局
Proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission
时间窗: 30 minutes
次要结局
- Proportion of neonates with mild hypothermia (temperature 36.0-36.4°C) at NICU admission(30 minutes)
- Propoertions of neoantes with respiratory distress syndrome(3 days)
- Proportion of hyperthermic neonates (temperature >38.0°C) at NICU admission(30 minutes)
- Proportion of ineonates with ntraventricular hemorrhage (grade I-IV)(7 days)
- Proportion of deaths(3 months)
- Proportion of neonates with temperature less than 36.0°C at NICU admission(30 minutes)
- Temperature at 1 hour after NICU admission(1 hour)
- Proportion of neonates with late onset sepsis(14 days)
- Proportion of neonates with bronchopulmonary dysplasia(36 gestational weeks)
研究者
Daniele Trevisanuto
Professor
University Hospital Padova