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Randomized Controlled Trial
. 2022 Jan;42(1):110-115.
doi: 10.1038/s41372-021-01223-2. Epub 2021 Oct 11.

Stannsoporfin with phototherapy to treat hyperbilirubinemia in newborn hemolytic disease

Warren N Rosenfeld  1 , Mark L Hudak  2 , Nancy Ruiz  3 , Shiva Gautam  4 ; Jasmine Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Stannsoporfin with phototherapy to treat hyperbilirubinemia in newborn hemolytic disease

Warren N Rosenfeld et al. J Perinatol. 2022 Jan.

Abstract

Objective: To evaluate the efficacy and safety of tin mesoporphyrin (SnMP) in neonates with hyperbilirubinemia (HB) due to hemolysis.

Study design: This multicenter, placebo-controlled phase 2b study (NCT01887327) randomized newborns (35-42 weeks) with hemolysis started on phototherapy (PT) to placebo (Ctrl), SnMP 3.0 mg/kg, or SnMP 4.5 mg/kg given once IM within 30 min of initiation of PT.

Results: In all, 91 patients were randomized (Ctrl: n = 30; 3 mg/kg SnMP: n = 30; 4.5 mg/kg SnMP: n = 31). At 48 h TSB significantly increased in Ctrl by 17.5% (95% CI 5.6-30.7; p = 0.004) and significantly decreased by -13% (95% CI -21.7 to -3.2; p = 0.013) in the 3.0 mg/kg and by -10.5% (95% CI -19.4 to -0.6; p = 0.041) in the 4.5 mg/kg group. Decreases in SnMP groups were significant (p < 0.0001) vs Ctrl.

Conclusion: SnMP with PT significantly reduced TSB by 48 h. SnMP may be useful as a treatment for HB in neonates with hemolysis.

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References

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