A randomized control trial of phototherapy and 20% albumin versus phototherapy and saline in Kilifi, Kenya

<jats:title>Abstract</jats:title> <jats:sec> <jats:title>Objective</jats:title> <jats:p>The study evaluated the efficacy of phototherapy and 20% albumin infusion to reduce total serum bilirubin (TSB) in neonates with severe hyperbilirubinemia. The primary outcome was a reduction of TSB at the end of treatment. The secondary outcomes were the need for exchange transfusion, inpatient mortality, neurological outcomes at discharge, and development outcomes at 12-months follow-up.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>One hundred and eighteen neonates were randomly assigned to phototherapy and 20% albumin (n = 59) and phototherapy and saline (n = 69). The median age at admission was 5 (interquartile range (IQR) 3–6) days, and the median gestation was 36 (IQR 36–38) weeks. No significant differences were found in the change in TSB (Mann–Whitney <jats:italic>U </jats:italic>=609, <jats:italic>p </jats:italic>= 0.98) and rate of change in TSB per hour after treatment (Mann–Whitney <jats:italic>U </jats:italic>= 540, <jats:italic>p </jats:italic>= 0.39) between the two groups. There were no significant differences between the two groups in the proportion of participants who required exchange transfusion (χ<jats:sup>2</jats:sup> (2) = 0.36, p = 0.546); repeat phototherapy (χ<jats:sup>2</jats:sup> (2) = 2.37, p = 0.123); and those who died (χ<jats:sup>2</jats:sup> (2) = 0.92, p = 0.337). <jats:italic>Trial registration</jats:italic> The trial was registered in the International Standardized Randomized Controlled Trial Number (ISRCTN); trial registration number ISRCTN89732754.</jats:p> </jats:sec>