Abstract
This investigation aimed to assess the safety and efficacy of NeoLight’s Skylife phototherapy device for the treatment of hyperbilirubinemia. A prospective, two-arm, randomized, unblinded controlled investigation compared total serum bilirubin (TSB) levels at baseline and discharge for a new phototherapy device (Skylife) with an existing phototherapy treatment in newborn infants. The repeated-measures analysis of variance (RM-ANOVA) indicated a significant main effect for the treatment condition, F(1, 54) = 4.041, P = .049. Post hoc findings showed that the Skylife group had significantly lower TSB levels following treatment (n = 28, Mean = 11.36, SD = 1.69) compared with the standard of care group (n = 28, Mean = 12.37, SD = 2.08), t(54) = 2.01, P = .049). The Skylife phototherapy device was as effective as the currently used therapy, with a shift toward a more rapid decline in bilirubin levels. Using this device may potentially decrease the length of therapy and hospitalization.
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