Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part II
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 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 II is for preterm/low birth weight infant with or without plastic head cover used from 1 hour after birth until discharge or 24 hours after birth to assist with temperature regulation.
详细描述
Due to limited resources, hospitals in the developing world struggle to provide sufficient incubators and to maintain climate-controlled nurseries. Therefore, premature low birth weight infants continue to be at an increased risk of hypothermia throughout their hospitalizations. This study will compare the incidence of hypothermia in preterm/low birth weight infants randomized to receive WHO thermoregulation care (control groups) or WHO thermoregulation care and a plastic bag covering their torsos and lower extremities (intervention group) starting at one hour after birth and continued to discharge or 24 hours after birth, whichever occurs first. The axillary temperature of each infant will be taken one hour after birth, every subsequent 3-4 hours, and at discharge or 24 hours after birth when infants will be removed from the plastic bags. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 50% and a hypothesized 20% absolute risk reduction (40% 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 Hour 至 120 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated gestational age 29-36 6/7 weeks or birth weight 1400-2500g
- •Delivery in the hospital
排除标准
- •Infant admitted to the NICU
- •Birth weight less than 1400 gms
- •Abdominal wall defect or myelomeningocele
- •Major congenital anomalies
- •Blistering skin disorder
研究组 & 干预措施
Thermoregulation-standard care
Standard thermoregulation without a plastic bag from one hour after birth until discharge or 24 hours after birth, whichever comes first.
干预措施: Thermoregulation-standard care (Procedure)
Thermoregulation-with plastic bag
Thermoregulation with plastic bag covering torso and lower extremities from one hour after birth until discharge or 24 hours after birth to assist with thermoregulation. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first.
干预措施: Thermoregulation with plastic bag (Procedure)
结局指标
主要结局
Axillary temperature < 36.5 degrees Celsius
时间窗: Discharge or 24 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 as severe hypothermia.
次要结局
- Seizure(Up to 4 weeks)
- Sepsis(Up to 4 weeks)
- Necrotizing enterocolitis or intestinal perforation(Up to 4 weeks)
- Pneumothorax(Up to 4 weeks)
- Hyperthermia(Up to 4 weeks)
- Death(Up to 4 weeks)
- Respiratory Distress Syndrome (RDS)(Up to 4 weeks)
- Temperature and humidity(1-72 hours after birth)
研究者
Wally Carlo
Edwin M. Dixon Professor of Pediatrics
University of Alabama at Birmingham