A Randomized Trial to Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates in Developing Countries
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Axillary temperature 36.5-37.5 degrees Celsius
研究概览
简要总结
The overall hypothesis is that placing infants 1000-2500 grams in plastic bags when compared to routine care will reduce the risk of hypothermia (< 36.5 degrees C) without increasing hyperthermia (> 37.5 degrees C).
详细描述
Prevention
After consent, infants with estimated gestational age between 26-36.6 weeks or with expected birth weight 1000-2500 grams will be randomized to resuscitation per standard protocol or to resuscitation per standard protocol and plastic bag. The intervention group will be placed into a plastic bag covering the body and back and top of head (excluding face) prior to drying the body's surface. Resuscitation efforts continue per standard of care. The infant will remain in the bag through the admission process until his/her axillary temp is in the range of 36.5- 37.5 degrees Celsius. At this time, the bag will be discontinued and discarded. Standard temperature control will be continued per nursery standard. Skin-to-skin contact between mother and baby is not excluded; however, the infant will remain in the plastic bag. Infant's axillary temperature will be measured per nursery standard after discontinuation of plastic bag. The control group will receive standard of care thermoregulation. Secondary measures (i.e. blood pressures, glucose levels, weight gain, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, seizures, intraventricular hemorrhage, necrotizing enterocolitis, pulmonary hemorrhage, and death) will be recorded in both groups.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated gestational age 26-36.6 weeks or expected birth weight 1000-2500 grams.
- •Delivery in the hospital.
排除标准
- •Abdominal wall defect or myelomeningocele.
- •Major congenital anomaly.
- •Blistering skin disorder.
结局指标
主要结局
Axillary temperature 36.5-37.5 degrees Celsius
时间窗: 1-4 hours
Temperature taken per axilla for 1 minute
次要结局
- Bronchopulmonary dysplasia (BPD)(28 days after birth)
- Seizure(Duration of hospitalization-expected average of 4 weeks)
- Pneumothorax(Duration of hospitalization-expected average of 4 weeks)
- Death(Duration of hospitalization-expected average of 4 weeks)
- Blood pressure(Duration of hospitalization-expected average of 4 weeks)
- Respiratory Distress Syndrome (RDS)(Duration of hospitalization-expected average of 4 weeks)
- Blood glucose(Duration of hospitalization-expected average of 4 weeks)
- Weight gain(Duration of hospitalization-expected average of 4 weeks)
- Sepsis(Duration of hospitalization-expected average of 4 weeks)
- Necrotizing enterocolitis or intestinal perforation(Duration of hospitalization-expected average of 4 weeks)
- Pulmonary hemorrhage(Duration of hospitalization-expected average of 4 weeks)
- Major brain injury(Duration of hospitalization-expected average of 4 weeks)
研究者
Alicia Leadford, MD
Fellow Instructor, Department of Pediatrics, Division of Neonatology
University of Alabama at Birmingham
