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NCT Number: NCT00635375

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, 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.

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Key information

Age range

1 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christiana Hospital, Newark, Delaware, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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-

Treatment and study plan

LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy)

Device

35-50 mW/cm2/nm

Other names: BiliSoft blue LED fiberoptic blanket phototherapy

Metal halide phototherapy (Spot PT metal halide phototherapy)

Device

29.3-57.6 mW/cm2/nm

Other names: Spot PT metal halide phototherapy

LED bank phototherapy (Natus neoBlue LED bank phototherapy)

Device

12-35 mW/cm2/nm

Other names: Natus neoBlue LED bank phototherapy

Metal halide plus LED fiberoptic blanket phototherapy (BiliSoft and Spot PT)

Device

29.3-57.6 mW/cm2/nm and 35-50 mW/cm2/nm

Other names: BiliSoft and Spot PT

Primary outcomes

  1. 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

Secondary outcomes

  1. Combination Phototherapy Systems will show a 20% shorter treatment time compared to single treatment methods alone.

    Time frame: 14 months

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 13, 2008
Registry last updated
Jan 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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