Comparative Study of Phototherapy for Hyperbilirubinemia

NCT ID: NCT00635375

Last Updated: 2009-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

LED fiberoptic blanket phototherapy

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

35-50 mW/cm2/nm

2

metal halide phototherapy

Group Type: EXPERIMENTAL

Metal halide phototherapy (Spot PT metal halide phototherapy)

Intervention Type: DEVICE

29.3-57.6 mW/cm2/nm

3

LED bank phototherapy

Group Type: ACTIVE_COMPARATOR

LED bank phototherapy (Natus neoBlue LED bank phototherapy)

Intervention Type: DEVICE

12-35 mW/cm2/nm

4

Combination metal halide phototherapy plus LED fiberoptic blanket phototherapy

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Interventions

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

35-50 mW/cm2/nm

Intervention Type: DEVICE

Metal halide phototherapy (Spot PT metal halide phototherapy)

29.3-57.6 mW/cm2/nm

Intervention Type: DEVICE

LED bank phototherapy (Natus neoBlue LED bank phototherapy)

12-35 mW/cm2/nm

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

BiliSoft blue LED fiberoptic blanket phototherapy; Spot PT metal halide phototherapy; Natus neoBlue LED bank phototherapy; BiliSoft and Spot PT

Eligibility Criteria

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-

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

GE Healthcare

Principal Investigators

Wendy Sturtz, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Hospital

Locations

Christiana Hospital

Newark, Delaware, United States

University of Tennessee

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

8828882

Identifier Type: -

Identifier Source: org_study_id