Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part I
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 182
- 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 I is for preterm/low birth weight infant with or without plastic head cover used during resuscitation.
详细描述
This study will compare the incidence of hypothermia during the first hour after birth in preterm/low birth weight infants randomized to receive WHO thermoregulation care and a plastic bag (without drying) covering the torso and lower extremities (control group) or WHO thermoregulation care and a plastic bag (without drying) covering the torso, upper and lower extremities, and a portion of their head (intervention group). The axillary temperature of each infant will be taken initially within 15 minutes of birth and later at 1 hour after birth as the infant is removed from the plastic bag. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 41% and a 21% absolute risk reduction (51% relative risk reduction), a sample size of 182 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 1 Hour（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated gestational age 29-36 6/7weeks or birth weight 1,400-2500g
- •Delivery in the hospital
排除标准
- •Infant admitted to the NICU
- •Birth weight less than 1,400g
- •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 after birth
Temperature taken per axilla at one hour after birth. Temperatures 36.0-36.4 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
- Pneumothorax(Up to 4 weeks)
- Sepsis(Up to 4 weeks)
- Seizure(Up to 4 weeks)
- Respiratory Distress Syndrome (RDS)(Up to 4 weeks)
- Necrotizing enterocolitis or intestinal perforation(Up to 4 weeks)
- Death(Up to 4 weeks)
- Hyperthermia(Up to 4 weeks)
- Temperature and humidity(1-72 hours after birth)
研究者
Waldemar A. Carlo
Edwin M. Dixon Professor of Pediatrics, Director of Division of Neonatology
University of Alabama at Birmingham