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Comparative Study of Phototherapy for Hyperbilirubinemia
NCT00635375 · View on ClinicalTrials.gov ↗
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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 19 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00635375 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Delaware, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00635375?
This trial is sponsored by GE Healthcare, which has 19 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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