Lipid strategies to prevent intestinal failure-associated liver disease in neonates: A pilot trial.

BACKGROUND: Intestinal failure-associated liver disease (IFALD) occurs in up to 50% of neonates treated with prolonged parenteral nutrition. Preventative strategies for IFALD include soybean oil lipid emulsion (SOLE) minimization and use of mixed-oil intravenous lipid emulsions (ILE). We conducted a pilot study prospectively comparing these two ILE strategies in the prevention of IFALD in neonates who required abdominal surgery. METHODS: We randomized eligible neonates to SOLE at 1 g/kg/day (SOLE Min) or mixed-oil ILE containing fish oil (MOLE) at 3 g/kg/day. These treatment groups were also compared with historic controls who received SOLE at 2-3 g/kg/day (SOLE Historic). We defined IFALD as a direct bilirubin >2 mg/dl on two measurements. Secondary outcomes included laboratory, growth, clinical, and nutrition outcomes. RESULTS: A total of 24 prospective and 24 historic patients were included. There was no difference in the rate of IFALD. However, there was a difference in the weekly change of direct bilirubin levels (SOLE Historic +0.293 mg/dl/week vs MOLE, P < 0.001; SOLE Min +0.242 mg/dl/week vs MOLE, P < 0.001). The MOLE group also had a lower direct bilirubin at study completion (SOLE Historic, 1.7 ± 1.7 mg/dl; SOLE Min, 1.6 ± 1.4 mg/dl; MOLE, 0.4 ± 0.4 mg/dl; P = 0.002) and received greater total calories (P = 0.008). CONCLUSION: The rate of IFALD did not differ when comparing ILE strategies in neonates requiring abdominal surgery. However, the MOLE group maintained significantly lower direct bilirubin levels over time while receiving increased calories. This pilot study highlights the need for further randomized controlled trials comparing these ILE strategies.

Pediatric Smoflipid Therapy: Patient Response and Safety Concerns.

BACKGROUND: Intestinal failure-associated liver disease (IFALD) occurs in ≤85% of neonates receiving prolonged parenteral nutrition. Strategies for treatment of IFALD include alternative lipid therapies, such as Smoflipid (Fresenius Kabi). In this study, we reviewed our institutional Smoflipid use, including predictors of patient response and safety concerns. METHODS: This is a retrospective chart review of all pediatric patients who received Smoflipid therapy over a 2-year period at Riley Hospital for Children. Forty-two patients (89%) had cholestasis at the start of Smoflipid therapy and were included in group analysis. We compared patients based on response to Smoflipid therapy, identifying associations and predictors of patient response. We also documented patient safety concerns, including essential fatty acid deficiency (EFAD), rapid infusion, and compatibility/access issues. RESULTS: Sixteen patients (38%) with cholestasis had resolution with Smoflipid. Those patients with resolution were older at initiation (58 vs 33.5 days; P = .010), treated with Smoflipid for longer (85.5 vs 41 days; P = .001), and had lower direct bilirubin at the start of Smoflipid therapy (3.7 vs 5.2 mg/dL; P = .035). We identified multiple safety concerns, including EFAD (54%), rapid infusion (17%), and missed doses (51%). No patient characteristics were found to correlate with Smofllpid therapy and diagnosis of EFAD. CONCLUSION: In our patient population, Smoflipid therapy led to cholestasis resolution in patients with lower direct bilirubin or less-severe IFALD. Use of Smoflipid is also associated with significant safety concerns, and its use should be coupled with close monitoring in pediatric patients, particularly in neonates.