Comparative Study of Phototherapy for Hyperbilirubinemia

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

• Hyperbilirubinemia

Interventions

DEVICE

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

35-50 mW/cm2/nm

DEVICE

Metal halide phototherapy (Spot PT metal halide phototherapy)

29.3-57.6 mW/cm2/nm

DEVICE

LED bank phototherapy (Natus neoBlue LED bank phototherapy)

12-35 mW/cm2/nm

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

Sponsors & Collaborators

• GE Healthcare

  lead INDUSTRY

Principal Investigators

• Wendy Sturtz, MD · Christiana Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

1 Month

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-03-31

Primary Completion

2008-08-31

Completion

2008-08-31

Countries

• United States

Study Locations