Comparative Study of Phototherapy for Hyperbilirubinemia

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Hyperbilirubinemia

Clinical Trial Details

NCT number	NCT00635375
Study type	Interventional
Source	GE Healthcare
Contact
Status	Completed
Phase	N/A
Start date	March 2008
Completion date	August 2008

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00360204` - Improving Health Outcomes for New Mothers and Babies	Phase 3
Completed	`NCT00383318` - Demographic, Metabolic, and Genomic Description of Neonates With Severe Hyperbilirubinemia	N/A
Completed	`NCT00115544` - Safety and Pharmacology of Stanate	Phase 2
Completed	`NCT01622699` - Implementation of a Transcutaneous Bilirubinometer	N/A
Terminated	`NCT00741117` - Conjugated Hyperbilirubinemia and Pulse Oximetry	N/A
Completed	`NCT00288600` - Efficacy of High-dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease	Phase 4
Completed	`NCT02774434` - Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age	N/A
Completed	`NCT01550627` - Effect of Intravenous Fluid Supplementation on Serum Bilirubin and Cardiorespiratory Parameters in Preterm Infants During Phototherapy	Phase 0
Completed	`NCT00653874` - Transcutaneous Bilirubinometry in Healthy Term and Near-Term Neonates	Phase 3
Recruiting	`NCT03564678` - Levocarnitine and Vitamin B Complex in Treating PEG-Asparaginase or Inotuzumab Ozogamicin-Induced Hyperbilirubinemia in Patients With Acute Lymphoblastic Leukemia	Phase 2
Recruiting	`NCT04897113` - Study of Efficacy and Safety of the Plasmapheresis Method With Albumin Compensation Compared With the Plasmapheresis Method Without Albumin Compensation for Aging Biomarkers Correction in Men and Women Aged 40 to 55 Years Old	N/A
Recruiting	`NCT01944696` - Cycled Phototherapy: A Safer Effective Treatment for Small Premature Infants?	N/A
Completed	`NCT03195998` - Validity of Transcutaneous Bilirubin Monitoring in Preterm Infants
Terminated	`NCT02685189` - Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)
Completed	`NCT02446951` - Implementation of a Clinical Decision Rule for Treatment of Neonatal Jaundice in the Emergency Department
Terminated	`NCT01136577` - Light-emitting Diodes (LED) Phototherapy for Hyperbilirubinemia of Term Newborn	N/A
Completed	`NCT04271098` - The Investigation of the Causes of Hepatic Dysfunction in the Postoperative Period During Open-heart Surgeries
Completed	`NCT02691156` - Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants
Completed	`NCT00004382` - Phase II Study of Tin Mesoporphyrin vs Phototherapy for Hyperbilirubinemia in Premature Newborns	Phase 2
Completed	`NCT00004381` - Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia	Phase 2