1. Stannsoporfin with phototherapy to treat hyperbilirubinemia in newborn hemolytic disease
- Author
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Rana Alissa, N. Shafi, A. Jewell, Shiva Gautam, W. Wong, Anna L. Brown, N. Katof, L. Bettica, W. Rosenfeld, A. Barringham, J. Nason, M. Hudak, Mark L. Hudak, O. Fofah, S. Kicklighter, Karen E. Shattuck, K. Pollock, Dan L. Stewart, F. Banfro, Nancy Ruiz, Ramasubbareddy Dhanireddy, A. Eldemerdash, L. G. Camp, R. Bimbi, Jaeyeoul Kim, L. Meloy, F. D. Kehinde, Warren Rosenfeld, D. Reyes, P. Smith, Carol L. Wagner, A. Maddox, G. Rhodes Ryan, E. Maduekwe, Nazeeh Hanna, Susan E. Richter, L. Clark, V. Lowery, B. Chakraborty, M.R. Thomas, and S. Crawford
- Subjects
medicine.medical_specialty ,business.industry ,Internal medicine ,Pediatrics, Perinatology and Child Health ,medicine ,Tin-mesoporphyrin ,Obstetrics and Gynecology ,Stannsoporfin ,Placebo ,medicine.disease ,business ,Gastroenterology ,Hemolysis - 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
- Published
- 2021
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