• Neonatology · Jan 2014

    Randomized Controlled Trial Comparative Study

    A double-blind randomised controlled trial of fish oil-based versus soy-based lipid preparations in the treatment of infants with parenteral nutrition-associated cholestasis.

    • Hugh S Lam, Yuk H Tam, Terence C W Poon, Hon M Cheung, Xinting Yu, Brenda P L Chan, Kim H Lee, Benjamin S C Lee, and Pak C Ng.
    • Department of Paediatrics, The Chinese University of Hong Kong, Prince of Wales Hospital, Sha Tin, Hong Kong.
    • Neonatology. 2014 Jan 1; 105 (4): 290-6.

    BackgroundInfants receiving prolonged parenteral nutrition (PN) are at risk of PN-associated cholestasis (PNAC). This can progress to hepatic failure and death if PN cannot be discontinued. Fish oil-based parenteral lipid preparation (FOLP) has been shown to be beneficial in case studies.Objectives(1) To evaluate whether FOLP could halt or reverse the progression of PNAC compared with soy-based parenteral lipid preparation (SLP) and (2) to assess the effects of FOLP on liver function and physical growth.MethodsDesigndouble-blind randomised controlled trial.Settinglevel III neonatal intensive care unit.Participantsinfants with PNAC (plasma-conjugated bilirubin concentration ≥ 34 µmol/l or 2 mg/dl) expected to be PN-dependent for >2 weeks.Interventionto receive either FOLP or SLP at 1.5 g/kg/day.Primary Outcome Measurereversal of PNAC within 4 months after commencement of lipid treatment; secondary outcomes: rate of change of weekly liver function tests, infant growth parameters, blood lipid profile and episodes of late-onset sepsis.ResultsA total of 9 infants were randomised to the FOLP group and 7 to the SLP group. There was no significant difference in reversal of PNAC at 4 months between groups. Rates of increase of plasma-conjugated bilirubin and alanine aminotransferase in the SLP group were significantly greater than the FOLP group (13.5 vs. 0.6 µmol/l per week and 9.1 vs. 1.1 IU/l per week, respectively, p = 0.03). Increased enteral nutrition was associated with significant improvement of PNAC in infants receiving FOLP compared with SLP (-8.5 vs. -1.6 µmol/l per 10% increase in enteral nutrition, respectively). The study was terminated prematurely.Conclusionsprogression of PNAC in PN-dependent infants can be halted by replacing SLP with FOLP and reversed by increasing the proportion of enteral nutrition in infants receiving FOLP. Replacement of SLP with FOLP in PN-dependent infants who develop PNAC may be considered.

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