Background Sepsis-associated cholestasis (SAC) is an intrahe-

Background Sepsis-associated cholestasis (SAC) is an intrahe-epsis-associated cholestasis (SAC) is an intrahepatic cholestasis caused by inflammatory cytokines. Patients with this condition have poor prognoses. Antibiotics are the mainstay of therapy, however, other adjuvant therapies, such as ursodeoxycholic acid (UDCA), have not been well established. Objective To assess the effect of UDCA for treatment of neonatal sepsis-associated cholestasis. Methods We performed a randomized, double-blind, controlled trial in 37 neonates who were diagnosed with sepsis-associated cholestasis in the Neonatal Care Unit of Cipto Mangunkusumo Hospital. Subjects were divided into two groups, with 19 neonates randomly allocated to the intervention group (received UDCA at 30 mg/kg/day divided into 3 doses for 7 days) and 18 neonates to the control group (received placebo). After 7 days of treatment, we evaluated the subjects' liver function parameters and performed a survival analysis. Results Liver function parameter improvements at day 7 were not significantly different between the UDCA group and the control group, including for mean decrease of total bilirubin (TB) levels [2.2 (SD 2.9) mg/dL vs 1.7 (SD 4.6) mg/dL; P=0.080), mean decrease of direct bilirubin (DB) levels [1.1 (SD 2.3) mg/dL vs 0.6 (SD 3.6) mg/dL; P=0.080), median indirect bilirubin (IB) levels [0.4 (range 0.1-5.6) mg/dL vs 0.9 (range 0.1-4.1) mg/dL; P=0.358), mean decrease of alanine aminotransferase (ALT) levels [0.5 (-80.0-21.0) U/L vs-2.0 (ranged-167.0-85.0) U/L; P= 0.730), median aspartate aminotransferase (AST) levels [43.0 (range 14.0-297.0) U/L vs 150.0 (range 24.0-840.0) U/L; P=0.081), and median gamma-glutamyl transpeptidase (GGT) levels [125.0 (48.0-481.0) U/L vs 235.0 (56.0-456.0) U/L; P=0.108)]. Five neonates in control group died compared to two in the UDCA group (P=0.232). In addition, UDCA did not significantly lengthen the survival time (hazard ratio/HR 3.62; 95%CI 0.69 to 18.77). Conclusion Ursodeoxycholic acid tends to improve total bilirubin, direct bilirubin, and AST levels in sepsis associated cholestasis. [Paediatr Indones. 2014;54:206-12.].