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

ObjectiveThe 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.ResultsOne 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 U=609, p=0.98) and rate of change in TSB per hour after treatment (Mann-Whitney U=540, p=0.39) between the two groups. There were no significant differences between the two groups in the proportion of participants who required exchange transfusion (chi (2) (2)=0.36, p=0.546); repeat phototherapy (chi (2) (2)=2.37, p=0.123); and those who died (chi (2) (2)=0.92, p=0.337). Trial registration The trial was registered in the International Standardized Randomized Controlled Trial Number (ISRCTN); trial registration number ISRCTN89732754.