Objectives: To assess the efficacy of SnMP in: a. moderating the need for phototherapy (PT) of full-term infants with plasma bilirubin concentrations (PBC) of 15-18 mg/dL; b. diminishing the time required for the PBC to decline to ≥ 13 mg/dL (closure of the case);c. lessening the need for bilirubin determinations for monitoring hyperbilirubinemia.
Subjects: Healthy full-term infants were enrolled with a PBC of 15 mg/dL - 18 mg/dL reached between 48 - 96 hours of age.
Design/Methods: After obtaining informed consent infants were randomized to the SnMP (6.0 μmol/kg BW, single dose I.M.) group or the control group. They were followed daily in hospital or at discharge as outpatients until hyperbilirubinemia subsided (PBC 13 mg/dL or less). The total number of infants enrolled was 84. Groups were similar in sex ratio, birth weight, gestational age, PBC and age at enrollment. PT was initiated at a PBC of 19.5 mg/dL.
Results: SnMP eliminated the need for supplemental PT (n=40; 0% PT) compared to controls (n=44; 27% PT) (P=0.0004); markedly diminished the hours to case closure (SnMP: median 86.5; min/max 24-216; controls median 120; min/max 72-336; [p=0.0006]) and significantly diminished the number of bilirubin determinations required for clinical monitoring (SnMP: median 3; min/max 1-9; controls: median 5; min/max 3-11) (p=0.0001). No SnMP-treated infants reached a PBC of 19.5 mg/dL; no side effects of SnMP use were detected.
Conclusion: A single dose of SnMP proved highly effective in eliminating the need for PT in severe hyperbilirubinemia in full-term newborns and in reducing use of medical resources for its management and the related, important and painful emotional costs for mothers and babies of this problem.
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(Spon by: Jerold Lucey, M.D.) Supported by the Renfield Fund and the NICHHD (NO1-HD-5-3234).
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Martinez, J., Garcia, H., Otheguy, L. et al. Control of severe hyperbilirubinemia in full-term newborns with the inhibitor of bilirubin production Sn-mesoporphyrin (SnMP) • 1067. Pediatr Res 43 (Suppl 4), 183 (1998). https://doi.org/10.1203/00006450-199804001-01088
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DOI: https://doi.org/10.1203/00006450-199804001-01088
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