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NCT00635375 · ClinicalTrials.gov registry record · NA
Comparative Study of Phototherapy for Hyperbilirubinemia
A NA study of Hyperbilirubinemia, sponsored by GE Healthcare.
- Completed
- Registry status
- NA
- Development phase
- 82
- Enrollment target
- 2
- Study locations
NCT00635375 is a NA study of Hyperbilirubinemia that has completed, run by GE Healthcare. The registered enrollment target is 82 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT00635375, a NA study of Hyperbilirubinemia, has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- NA
- Development phase
- 82 participants
- Enrollment target
- 2
- Study locations
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.
Conditions Studied
Interventions
- 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 Locations (2)
Delaware
- Christiana Hospital - Newark
Tennessee
- University of Tennessee - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2008-03 |
| Est. Completion | 2008-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00635375
The ClinicalTrials.gov registry entry for NCT00635375 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GE Healthcare, which has 99 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hyperbilirubinemia appearing as the primary indexed condition, and to 4 interventions - of which LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy) is the first listed.
NCT00635375 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Delaware, Tennessee.
Frequently Asked Questions
What is clinical trial NCT00635375 about?
NCT00635375 is a clinical study titled "Comparative Study of Phototherapy for Hyperbilirubinemia". 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, mu...
What is the current status of trial NCT00635375?
This trial is currently completed. It is a NA study. The enrollment target is 82 participants. The study started on 2008-03. Estimated completion is 2008-08.
What conditions does trial NCT00635375 study?
This clinical trial studies the following conditions: Hyperbilirubinemia.
What interventions are being tested in trial NCT00635375?
The interventions under investigation include: 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) (DEVICE).
Who is sponsoring clinical trial NCT00635375?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00635375 being conducted?
This trial has 2 study locations across Delaware, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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