跳至主要内容
临床试验/NCT01403623
NCT01403623已完成4 期

A Randomized Trial to Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates in Developing Countries

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2011年8月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alicia Leadford, MD

Fellow Instructor, Department of Pediatrics, Division of Neonatology

University of Alabama at Birmingham

研究点 (1)

Loading locations...

相似试验