Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia
OBJECTIVES: I. Compare the efficacy of preventive vs. therapeutic tin mesoporphyrin in direct Coombs' test-positive ABO hemolytic disease of the newborn and glucose-6-phosphate dehydrogenase deficiency in infants living in Greece.
II. Assess the safety of tin mesoporphyrin in high-risk newborns.
|Glucosephosphate Dehydrogenase Deficiency Hyperbilirubinemia Hemolytic Disease of Newborn||Drug: tin mesoporphyrin||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||December 1999|
PROTOCOL OUTLINE: Patients are stratified by gestational age and sex, and randomly assigned in pairs per stratum.
One group receives a preventive dose of tin mesoporphyrin. Another group receives a therapeutic dose of tin mesoporphyrin according to the plasma bilirubin concentration.
Patients in either group may be treated concurrently with phototherapy or exchange transfusion if clinically indicated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004381
|United States, Massachusetts|
|New England Medical Center Hospital|
|Boston, Massachusetts, United States, 02111|
|United States, New York|
|Rockefeller University Hospital|
|New York, New York, United States, 10021-6399|
|Study Chair:||Attallah Kappas||Rockefeller University|