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临床试验/NCT00635375
NCT00635375已完成不适用

A Comparative Study Between BiliSoft Blue LED Fiberoptic Blanket Phototherapy, Giraffe Spot PT Phototherapy, Natus Blue LED Bank Light Phototherapy, and BiliSoft + Giraffe Spot PT Combination Therapy

GE Healthcare4 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
GE Healthcare
入组人数
82
试验地点
4
主要终点
The LED Fiberoptic Phototherapy System and metal halide spot phototherapy are will show no difference in therapeutic treatment times compared to the LED Bank Light System.

研究概览

简要总结

Hyperbilirubinemia is a common problem for term and preterm newborns in intensive care nurseries around the world. It is a condition in which there is too much bilirubin in the blood. Bilirubin is a substance that is naturally released when red blood cells break down. In the early newborn period, multiple factors lead to an abnormally elevated bilirubin level. Large amounts of bilirubin can circulate to tissues in the brain and may cause seizures or brain damage. About 6.1% of term newborns and a higher percentage of preterm newborns develop hyperbilirubinemia that requires treatment. Initiating treatment depends on many factors, including the cause of the hyperbilirubinemia, the level of serum indirect bilirubin, the rate of indirect bilirubin rise, and the age of the patient. The goal of treatment is to keep the level of bilirubin from rising to dangerous levels.

The bilirubin molecule absorbs light. Therefore, treatment of hyperbilirubinemia involves exposure of the baby's skin to special blue spectrum light. Phototherapy is globally recognized as the standard of care for treatment of elevated indirect hyperbilirubinemia in the neonatal period. This light exposure converts water-insoluble indirect bilirubin to a more easily excreted soluble molecule. Over the last five years, several devices have been introduced that emit high intensity light in the blue portion of the visible light spectrum. However, despite frequent use of such therapy, the effectiveness of different phototherapy devices has not been adequately compared. The objective of this study is to compare the efficacy of the blue LED fiberoptic phototherapy with the metal halide spot phototherapy versus blue LED bank light phototherapy versus a combination of tandem therapy on lowering to total serum bilirubin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Day 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • > 23 0/7 weeks gestation
  • > 500 grams
  • Non-hemolytic or presumed physiologic jaundice (within the first 14 days of life)

排除标准

  • Known congenital infection (proven bacterial or viral etiology)
  • Known hemolytic diseases such as but not limited to ABO or Rh incompatibility, minor blood group incompatibility, glucose-6-phosphate dehydrogenase deficiency, or hereditary red blood cell membrane defects (Coombs or DAT positive)
  • Suspected genetic, syndromic, or hepatic disorder-

结局指标

主要结局

The LED Fiberoptic Phototherapy System and metal halide spot phototherapy are will show no difference in therapeutic treatment times compared to the LED Bank Light System.

时间窗: 14 months

次要结局

  • Combination Phototherapy Systems will show a 20% shorter treatment time compared to single treatment methods alone.(14 months)

研究者

发起方
GE Healthcare
申办方类型
Industry

研究点 (4)

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