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Comparative Study of Phototherapy for Hyperbilirubinemia
This study has been completed.
First Received: March 5, 2008   Last Updated: January 9, 2009   History of Changes
Sponsored by: GE Healthcare
Information provided by: GE Healthcare
ClinicalTrials.gov Identifier: NCT00635375
  Purpose

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
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)

MedlinePlus related topics: Jaundice
U.S. FDA Resources
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

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • The LED Fiberoptic Phototherapy System and metal halide spot phototherapy are will show no difference in therapeutic treatment times compared to the LED Bank Light System. [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Combination Phototherapy Systems will show a 20% shorter treatment time compared to single treatment methods alone. [ Time Frame: 14 months ] [ Designated as safety issue: No ]

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
1: Experimental
LED fiberoptic blanket phototherapy
Device: LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy)
35-50 mW/cm2/nm
2: Experimental
metal halide phototherapy
Device: Metal halide phototherapy (Spot PT metal halide phototherapy)
29.3-57.6 mW/cm2/nm
3: Active Comparator
LED bank phototherapy
Device: LED bank phototherapy (Natus neoBlue LED bank phototherapy)
12-35 mW/cm2/nm
4: Experimental
Combination metal halide phototherapy plus LED fiberoptic blanket phototherapy
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

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 23 0/7 weeks gestation
  • > 500 grams
  • Non-hemolytic or presumed physiologic jaundice (within the first 14 days of life)

Exclusion Criteria:

  • Known congenital infection (proven bacterial or viral etiology)
  • Known hemolytic diseases such as but not limited to ABO or Rh incompatibility, minor blood group incompatibility, glucose-6-phosphate dehydrogenase deficiency, or hereditary red blood cell membrane defects (Coombs or DAT positive)
  • Suspected genetic, syndromic, or hepatic disorder-
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00635375

Locations
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
United States, Tennessee
University of Tennessee
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
GE Healthcare
Investigators
Principal Investigator: Wendy Sturtz, MD Christiana Hospital
  More Information

No publications provided

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

Study placed in the following topic categories:
Hyperbilirubinemia

Additional relevant MeSH terms:
Pathologic Processes
Hyperbilirubinemia

ClinicalTrials.gov processed this record on May 07, 2009