Hyperbilirubinemia Clinical Trial
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.
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.
;
Primary Purpose: Treatment
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