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Comparative Study of Phototherapy for Hyperbilirubinemia

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clinicaltrials.gov/study/NCT00635375
Is a
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Clinical study
0

Clinical Study attributes

NCT Number
NCT006353750
Trial Recruitment Size
820
Trial Sponsor
GE Healthcare
GE Healthcare
0
Clinical Trial Start Date
2008
0
Primary Completion Date
2008
0
Study Completion Date
2008
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Device0
Interventional Trial Phase
Not Applicable0
Participating Facility
University of Tennessee
University of Tennessee
0
Official Name
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 Therapy0
Last Updated
January 13, 2009
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
Metal halide phototherapy (Spot PT metal halide phototherapy)0
Metal halide plus LED fiberoptic blanket phototherapy (BiliSoft and Spot PT)0
LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy)0
LED bank phototherapy (Natus neoBlue LED bank phototherapy)0
Study summary

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.

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