Comparative Study of Phototherapy for Hyperbilirubinemia

NCT00635375 | Completed

• 1 other identifier: 8828882
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

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.

  14 months

Secondary Outcomes (1)

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

  14 months

Study Arms (4)

1

EXPERIMENTAL

LED fiberoptic blanket phototherapy

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

2

EXPERIMENTAL

metal halide phototherapy

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

3

ACTIVE COMPARATOR

LED bank phototherapy

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

4

EXPERIMENTAL

Combination metal halide phototherapy plus LED fiberoptic blanket phototherapy

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

Interventions

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

35-50 mW/cm2/nm

Also known as: BiliSoft blue LED fiberoptic blanket phototherapy

1

Metal halide phototherapy (Spot PT metal halide phototherapy) DEVICE

29.3-57.6 mW/cm2/nm

Also known as: Spot PT metal halide phototherapy

2

LED bank phototherapy (Natus neoBlue LED bank phototherapy) DEVICE

12-35 mW/cm2/nm

Also known as: Natus neoBlue LED bank phototherapy

3

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

Also known as: BiliSoft and Spot PT

4

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \> 23 0/7 weeks gestation
• \> 500 grams
• Non-hemolytic or presumed physiologic jaundice (within the first 14 days of life)

You may not qualify if:

• 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-

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (2)

Christiana Hospital

Newark, Delaware, 19718, United States

Location

University of Tennessee

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wendy Sturtz, MD

  Christiana Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: March 13, 2008
• Study Start: March 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: January 13, 2009

Record last verified: 2009-01

Locations

US (2)