Direct comparison of Sn-mesoporphyrin, an inhibitor of bilirubin production, and phototherapy in controlling hyperbilirubinemia in term and near-term newborns. Control of severe hyperbilirubinemia in full-term newborns with the inhibitor of bilirubin production Sn-mesoporphyrin.
Sn-mesoporphyrin (SnMP) is a potent inhibitor of bilirubin production. In our previous studies a single dose (6 mumol/kg birth weight) significantly moderated hyperbilirubinemia and reduced phototherapy (PT) time by > 75% when administered within 24 hours of birth to preterm infants.
                To directly compare the efficacy of SnMP and PT for controlling hyperbilirubinemia in term and near-term infants.
                Two randomized, sequentially analyzed trials (Study I: male term infants; Study II: infants of both sexes and gestational age [GA] 245-265 days) were conducted. SnMP (6 mumol/kg birth weight) or PT (Phillips F20T12/BB lamps) was administered to paired infants according to strict criteria of plasma bilirubin levels and age. Time of enrollment and closure of cases and crossover, if necessary, of SnMP infants to PT or all infants to exchange transfusion were precisely defined in each pair. SnMP or PT was considered superior if the time between enrollment and closure of the case was reduced by > 24 hours over the alternative treatment or if crossover had occurred.
                None of the 44 SnMP-treated infants required supplemental PT. Of the 22 pairs of term infants enrolled in Study I, SnMP proved superior to PT in 20 and equal in two. Of the 20 pairs of near-term infants enrolled in Study II, SnMP was superior in 12 and PT in two; six were tied. Two SnMP-treated infants were unpaired. The PT-treated infants in Study I required an average of 33 hours of treatment; those in Study II, 48 hours. None of the enrolled infants required exchange transfusion or interruption of breast-feeding. In both studies, times between case enrollment and closure were reduced by > 30 hours in SnMP compared with PT infants; requirements for additional days of medical observation and bilirubin measurements were also significantly less in SnMP infants.
                A single dose of SnMP entirely supplanted the need for PT in jaundiced term and near-term newborns and significantly reduced medical resource use to monitor hyperbilirubinemia. To assess the efficacy of Sn-mesoporphyrin (SnMP), a potent inhibitor of bilirubin production, in: a) moderating the need for phototherapy (PT) in full-term breastfed infants with plasma bilirubin concentrations (PBC) of >/=256.5 micromol/L and </=307.8 micromol/L (>/=15 mg/dL and </=18 mg/dL, respectively) that were reached between >/=48 and </=96 hours of age; b) diminishing the time required for the PBC to decline to </=222.3 micromol/L (</=13 mg/dL) (closure of the case); c) decreasing the number of bilirubin determinations required for monitoring hyperbilirubinemia.
                Healthy full-term breastfed infants with a PBC between >/=256.5 micromol/L and </=307.8 micromol/L (>/=15 mg/dL and </=18 mg/dL, respectively) reached between 48 to 96 hours of age.
                After obtaining informed consent from the parents, infants were randomized to either the SnMP (6.0 micromol/kg birth weight, single dose, intramuscular) group or the control group. The infants' PBCs were followed by daily measurements either in the hospital or at discharge as outpatients until the hyperbilirubinemia had subsided (PBC </=222.3 micromol/L [13mg/dL]). The total number of newborns enrolled in the study was 84; the SnMP group comprised 40 infants; the control group comprised 44 infants. The groups were similar in sex ratio, birth weight, gestational age, PBC, and age at enrollment. All infants were breastfed. Phototherapy was initiated at a PBC of 333.5 micromol/dL (19.5 mg/dL).
                SnMP entirely eliminated the need for supplemental PT to control hyperbilirubinemia; in contrast, of the 44 control infants, 12 required treatment with PT (27%) when their PBC reached or exceeded the level (333.5 micromol/dL; 19.5 mg/dL) at which time the use of PT was dictated by hospital guidelines. None of the 40 SnMP-treated infants reached a PBC of 19.5 mg/dL. SnMP also markedly diminished the median hours to case closure (SnMP: median, 86.5 hours; minimum/maximum, 24/216 hours; controls: median, 120 hours; minimum/maximum, 72/336 hours); and significantly reduced the number of bilirubin determinations required for clinical monitoring of the infants (SnMP: median, 3; minimum/maximum, 1/9; controls: median, 5; minimum/maximum, 3/11). No adverse effects of SnMP use were observed.
                A single dose of SnMP proved effective in controlling severe hyperbilirubinemia in full-term breastfed newborns with high bilirubin levels between 48 and 96 hours. In addition, SnMP eliminated the need for PT and reduced the use of medical resources in the clinical treatment of this problem as well as the related, important and painful, emotional costs for both mothers and infants.