Background In neonates, parenteral nutrition associated liver disease (PNALD) is a well-documented complication. Few retrospective studies suggested that ursodeoxycholic acid (UDCA) may shorten cholestasis duration.
Objectives To evaluate the effect of UDCA treatment on the duration and severity of PNALD.
Design/methods A double blinded randomised controlled pilot study in a level III NICU. PNALD was defined as at least 2 values of conjugated bilirubin ≥ 34 μmol/L. UDCA or placebo was started after randomization within 72 h of the diagnosis. Exclusion criteria included biliary tract anomalies, TORCH infection, short bowel syndrome, congenital hypothyroid, urinary tract infection, and congenital metabolic or genetic disorders. Baseline characteristics, clinical and biochemical evolution information were collected. Student’s T test, Chi-squared or Fisher’s exact test were used as appropriate. p < 0.05 was considered significant.
Results After consent, 26 infants were recruited (14 placebo and 12 UDCA). Table1 shows baseline characteristics. In the intention to treat analysis, there was no difference in the duration of cholestasis between groups. In the per protocol analysis (after excluding 2 deaths and one transfer in the placebo group, 4 deaths and one exclusion criteria violation in the UDCA group) the duration of cholestasis was significally shorter in the UDCA group. Figures1, 2 show the effect of UDCA on the duration of cholestasis and the maximum values of hepatic markers. No adverse reactions were associated with UDCA treatment.
Conclusion In neonates, treatment with UDCA decreases the duration of cholestasis. The UDCA group showed lower maximum hepatic transaminases levels indicating possible hepatic protective effect.