Comparative Study of Phototherapy for Hyperbilirubinemia



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:10/14/2017
Start Date:March 2008
End Date:August 2008

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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.


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-
We found this trial at
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Knoxville, Tennessee 37920
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Knoxville, TN
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Newark, Delaware 19718
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Newark, DE
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