Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part V
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Axillary temperature < 36.5 degrees Celsius
研究概览
简要总结
The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part V is comparing standard WHO thermoregulation practices plus use of a plastic torso wrap to no plastic torso wrap in full term infants from resuscitation to one hour after birth.
详细描述
Due to delivery rooms without adequate climate controls, even full term infants have high rates of hypothermia in the developing world. This study will compare the rates of hypothermia one hour after birth in full term infants randomized to receive standard WHO thermoregulation care (control group) or standard WHO thermoregulation care without immediate drying plus a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken within 15 minutes of birth at at one hour after birth with removal of the plastic bag. Hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 15% and a hypothesized 10% absolute risk reduction (66% relative risk reduction), a sample size of 276 will be used to have a power of 80% and a confidence interval of 95%.
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
- None
入排标准
- 年龄范围
- 1 Minute 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated gestational age 37 weeks and greater
- •Birth weight greater than 2,500gms
- •Delivery in the hospital
排除标准
- •Infant admitted to the NICU
- •Birth weight less than 2,500gms
- •Abdominal wall defect or myelomeningocele
- •Major congenital anomalies
- •Blistering skin disorder
结局指标
主要结局
Axillary temperature < 36.5 degrees Celsius
时间窗: 1-72 hours
Temperature taken per axilla at one hour after birth. Temperatures 36.0-16.4 will be classified as mild hypothermia, 32.0-35.9 will be classified as moderate hypothermia, and \< 32.0 will be classified as severe hypothermia.
次要结局
- Sepsis(Up to 72 hours)
- Death(Up to 72 hours)
- Hyperthermia(Up to 72 hours)
- Room Temperature(1-72 hours)
研究者
Waldemar A. Carlo, MD
Edwin M. Dixon Professor of Pediatrics
University of Alabama at Birmingham