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

Abstract

Background: Infants 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. Methods: Design: double-blind randomised controlled trial. Setting: level III neonatal intensive care unit. Participants: infants with PNAC (plasma-conjugated bilirubin concentration ≥34 µmol/l or 2 mg/dl) expected to be PN-dependent for >2 weeks. Intervention: to receive either FOLP or SLP at 1.5 g/kg/day. Primary outcome measure: reversal 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. Results: A 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. Conclusions: progression 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.

Early Reoperations after Primary Repair of Jejunoileal Atresia in Newborns

“…However, the only mortality case in the present study resulted from sepsis with parenteral nutrition-related liver failure. This patient died before our introduction of fish oil-based lipid preparation in parenteral nutrition which carries a lower risk to liver injury [18]. Total parenteral nutrition was required in 47 to 79% of neonates after operation for JIA, and dependency was significantly associated with the length of remaining small bowel [5][6][7].…”

Lipid Emulsion Use in Pediatric Patients Requiring Long‐Term Parenteral Nutrition

“…There have been efforts to prevent or reverse cholestasis by modifying lipid administration in patients requiring long‐term PN. Modifications include lipid minimization, temporarily discontinuing lipids, and using lipid emulsions containing lipid sources other than soybean oil (eg, pure fish oil or composite lipid emulsions with or without fish oil) …”

Visceral transplantation in patients with intestinal-failure associated liver disease: Evolving indications, graft selection, and outcomes

“…Multiple subsequent studies using various formulations of fish oil lipid emulsions have consistently demonstrated resolution of cholestasis in patients with IFALD. (36–39)…”