Phase II Study of Tin Mesoporphyrin vs Phototherapy for Hyperbilirubinemia in Premature Newborns
OBJECTIVES: I. Compare the effectiveness of a single dose of tin mesoporphyrin and special blue light phototherapy in controlling hyperbilirubinemia in premature newborns in Greece.
II. Evaluate the dose of tin mesoporphyrin sufficient to alleviate the need for phototherapy without adverse effects in these newborns.
|Hyperbilirubinemia||Drug: tin mesoporphyrin Procedure: Phototherapy||Phase 2|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||December 1999|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
PROTOCOL OUTLINE: Patients are randomly assigned to a clinical group within 96 hours of birth. Patients are stratified by gestational age, clinical status, and age at treatment.
One group receives tin mesoporphyrin. Patients are crossed to phototherapy if the plasma bilirubin concentration reaches the treatment threshold.
The second group receives phototherapy with Special Blue fluorescent lamps for at least 24 hours. Patients receive a second phototherapy course if the plasma bilirubin concentration reaches the treatment threshold within 24 hours of the first course.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004382
|Study Chair:||Attallah Kappas||Rockefeller University|