Stannsoporfin with phototherapy to treat hyperbilirubinemia in newborn hemolytic disease

The Jasmine Study Group

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
JournalJournal of Perinatology
DOIs
StateAccepted/In press - 2021

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health
  • Obstetrics and Gynecology

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