Effect of Drying Before Plastic Wrapping on Thermal Losses in Very Preterm Infants at Birth: a Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- Number (percentage) of neonates in the normal thermal range (temperature 36.5-37.5°C) at Neonatal Intensive Care Unit admission.
研究概览
简要总结
This is a multicenter, unblinded, randomized controlled trial comparing drying vs. not drying before plastic wrapping for the thermoregulation of very preterm infants at birth. The aim of this study will be to compare two modes of thermal management (plastic wrapping with or without drying) for preventing heat loss at birth in very preterm infants.
详细描述
Background: 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. While drying is recommended for the thermal management of infants with gestational age >32 weeks, this procedure is not indicated for very preterm infants who should be put in a plastic wrap immediately at birth without drying. However, such indication is based on studies comparing wrapping without drying vs. drying without wrapping, while the potential advantages of combining these interventions were not explored. We hypothesized that drying before wrapping could prevent heat loss immediately after birth and reduce hypothermia at NICU admission in very preterm infants.
Objective
The aim of this study will be to compare two modes of thermal management (plastic wrapping with or without drying) for preventing heat loss at birth in very preterm infants.
Methods: This is a multicenter, unblinded, randomized controlled trial comparing drying vs. not drying before plastic wrapping for the thermoregulation of very preterm infants at birth. After obtaining parental consent, all infants with estimated birth weight <1500 g and/or gestational age ≤30+6 weeks will be assigned to be managed with or without drying before plastic wrapping. Room temperature and maternal temperature will be measured at the time of delivery. Patients allocated in both groups will be managed based on the current guidelines for neonatal resuscitation. The primary outcome measure will be the proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission. Secondary outcome measures will be: proportion of neonates with hypothermia (<36.5°C and <36.0°C) at NICU admission; proportion of hyperthermic neonates (temperature >37.5°C) at NICU admission; temperature at 1 hour after NICU admission; proportion of intraventricular hemorrhage; proportion of respiratory distress syndrome; proportion of late onset sepsis; proportion of bronchopulmonary dysplasia; mortality before hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Minutes 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Estimated birth weight <1500 g and/or gestational age ≤30+6 weeks (and)
- •Inborn (and)
- •Parental consent; written informed consent will be obtained by a member of the neonatal team involved in the study from a parent or guardian at the maternal admission to the Obstetric Department.
排除标准
- •Major congenital malformations (i.e. cardiac disease, defects of abdominal wall, ...);
- •Parental refusal to participate in the study.
研究组 & 干预措施
Drying before wrapping
Immediately after birth, the infant's body will be dried before wrapping in a plastic bag
干预措施: Drying before wrapping (Other)
No drying before wrapping
Immediately after birth, the infant will be wrapped in a plastic bag without drying
干预措施: No drying before wrapping (Other)
结局指标
主要结局
Number (percentage) of neonates in the normal thermal range (temperature 36.5-37.5°C) at Neonatal Intensive Care Unit admission.
时间窗: 25 minutes
次要结局
- Number (percentage) of neonates with hypothermia (temperature <36.5°C) at neonatal intensive care unit admission(25 minutes)
- Number (percentage) of neonates with moderate-severe hypothermia (temperature <36.0°C) at neonatal intensive care unit admission(25 minutes)
- Number (percentage) of neonates hyperthermia (temperature >37.5°C) at NICU admission at neonatal intensive care unit admission(25 minutes)
- Temperature at 1 hour after neonatal intensive care unit admission(60 minutes)
- Number (percentage) of infants with intraventricular hemorrhage (all grades and grade III-IV)(10 days)
- Number (percentage) of infants with respiratory distress syndrome(72 hours)
- Number (percentage) of infants with late-onset sepsis(7 days)
- Number (percentage) of infants with bronchopulmonary dysplasia(36 postnatal weeks)
- Number (percentage) of infants died before hospital discharge(5 months)
研究者
Daniele Trevisanuto
Associate Professor
University Hospital Padova