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Comparative Study of Phototherapy for Hyperbilirubinemia

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00635375
First received: March 5, 2008
Last updated: January 9, 2009
Last verified: January 2009
History of Changes

March 5, 2008
January 9, 2009
March 2008
August 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00635375 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Comparative Study of Phototherapy for Hyperbilirubinemia
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

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hyperbilirubinemia
  • Device: LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy)
    35-50 mW/cm2/nm
    Other Name: BiliSoft blue LED fiberoptic blanket phototherapy
  • Device: Metal halide phototherapy (Spot PT metal halide phototherapy)
    29.3-57.6 mW/cm2/nm
    Other Name: Spot PT metal halide phototherapy
  • Device: LED bank phototherapy (Natus neoBlue LED bank phototherapy)
    12-35 mW/cm2/nm
    Other Name: Natus neoBlue LED bank 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
    Other Name: BiliSoft and Spot PT
  • Experimental: 1
    LED fiberoptic blanket phototherapy
    Intervention: Device: LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy)
  • Experimental: 2
    metal halide phototherapy
    Intervention: Device: Metal halide phototherapy (Spot PT metal halide phototherapy)
  • Active Comparator: 3
    LED bank phototherapy
    Intervention: Device: LED bank phototherapy (Natus neoBlue LED bank phototherapy)
  • Experimental: 4
    Combination metal halide phototherapy plus LED fiberoptic blanket phototherapy
    Intervention: Device: Metal halide plus LED fiberoptic blanket phototherapy (BiliSoft and Spot PT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
August 2008
August 2008   (final data collection date for primary outcome measure)

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-
Both
up to 1 Month
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00635375
8828882
No
Lynn Lynam, MIC Clinical Programs & Research, GE Healthcare
GE Healthcare
Not Provided
Principal Investigator: Wendy Sturtz, MD Christiana Hospital
GE Healthcare
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP