Comparative Study of Phototherapy for Hyperbilirubinemia

General Electric (GE)

Status: Completed

Conditions: Hyperbilirubinemia

Treatments: Device: LED bank phototherapy (Natus neoBlue LED bank phototherapy); Device: Metal halide phototherapy (Spot PT metal halide phototherapy); Device: LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy); Device: Metal halide plus LED fiberoptic blanket phototherapy (BiliSoft and Spot PT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00635375

8828882

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: All

Ages: 1 day to 1 month old

Volunteers: No Healthy Volunteers

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-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 4 patient groups

1

Experimental group

Description:

LED fiberoptic blanket phototherapy

Treatment:

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

2

Experimental group

Description:

metal halide phototherapy

Treatment:

Device: Metal halide phototherapy (Spot PT metal halide phototherapy)

3

Active Comparator group

Description:

LED bank phototherapy

Treatment:

Device: LED bank phototherapy (Natus neoBlue LED bank phototherapy)

4

Experimental group

Description:

Combination metal halide phototherapy plus LED fiberoptic blanket phototherapy

Treatment:

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