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Sponsored by: |
GE Healthcare |
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Information provided by: | GE Healthcare |
ClinicalTrials.gov Identifier: | NCT00635375 |
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.
Condition | Intervention |
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Hyperbilirubinemia |
Device: LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy) Device: Metal halide phototherapy (Spot PT metal halide phototherapy) Device: LED bank phototherapy (Natus neoBlue LED bank phototherapy) Device: Metal halide plus LED fiberoptic blanket phototherapy (BiliSoft and Spot PT) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 82 |
Study Start Date: | March 2008 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
LED fiberoptic blanket phototherapy
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Device: LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy)
35-50 mW/cm2/nm
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2: Experimental
metal halide phototherapy
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Device: Metal halide phototherapy (Spot PT metal halide phototherapy)
29.3-57.6 mW/cm2/nm
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3: Active Comparator
LED bank phototherapy
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Device: LED bank phototherapy (Natus neoBlue LED bank phototherapy)
12-35 mW/cm2/nm
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4: Experimental
Combination metal halide phototherapy plus LED fiberoptic blanket phototherapy
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Device: Metal halide plus LED fiberoptic blanket phototherapy (BiliSoft and Spot PT)
29.3-57.6 mW/cm2/nm and 35-50 mW/cm2/nm
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Ages Eligible for Study: | up to 1 Month |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Delaware | |
Christiana Hospital | |
Newark, Delaware, United States, 19718 | |
United States, Tennessee | |
University of Tennessee | |
Knoxville, Tennessee, United States, 37920 |
Principal Investigator: | Wendy Sturtz, MD | Christiana Hospital |
Responsible Party: | GE Healthcare ( Lynn Lynam, MIC Clinical Programs & Research ) |
Study ID Numbers: | 8828882 |
Study First Received: | March 5, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00635375 History of Changes |
Health Authority: | United States: Institutional Review Board |
Hyperbilirubinemia |
Pathologic Processes Hyperbilirubinemia |