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NCT00635375 · ClinicalTrials.gov registry record · NA
Comparative Study of Phototherapy for Hyperbilirubinemia
A NA study of Hyper Bilirubinemia, sponsored by GE Healthcare.
- Completed
- Registry status
- NA
- Development phase
- 82
- Enrollment target
- 2
- Study locations
NCT00635375: Completed NA study of Hyper Bilirubinemia, sponsored by GE Healthcare.
NCT00635375 is a NA study of Hyper Bilirubinemia that has completed, run by GE Healthcare. The registered enrollment target is 82 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00635375, a NA study of Hyper Bilirubinemia, 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 |
What the finished NCT00635375 record still lists
NCT00635375 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Hyper Bilirubinemia 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 a single indexed study location in 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: Hyper Bilirubinemia.
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.
Learn More About Clinical Trials
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Where NCT00635375's enrollment target sits among peer trials
82 990th of 2000 higher than 1,009 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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