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
Hemolytic Disease of Newborn
Drug: tin mesoporphyrin
|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.
|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|