Hyperbilirubinemia Clinical Trial
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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