Soybean-Oil Lipid Minimization for Prevention of Intestinal Failure-Associated Liver Disease in Late-Preterm and Term Infants With Gastrointestinal Surgical Disorders.

Background: Intestinal failure-associated liver disease (IFALD), a multifactorial disease, is common among infants with gastrointestinal surgical disorders (GISDs). Prolonged soy-based intravenous lipid emulsion (S-ILE) intake is associated with IFALD, but preventive studies of limiting S-ILE have been inconclusive. Furthermore, a double-blind, randomized preventive trial (DBRPT) of S-ILE intake has not been performed in infants with GISDs. Our objective was to compare the effect of 1 g/kg/d vs 2 g/kg/d S-ILE intake for 6 weeks on the incidence of IFALD and the rate of rise of direct bilirubin (DB) in infants with GISDs.

Methods: A DBRPT was conducted in infants with GISDs at ≥34 weeks' gestational age (GA) admitted to the NICU within 72 hours after birth. Infants were randomized in a 1:1 ratio to receive either 1 or 2 g/kg/d S-ILE for 6 weeks. IFALD was defined as DB ≥2 mg/dL.

Results: Forty infants were studied. The 2 groups had similar clinical characteristics except for GA and blood group incompatibility. Thirty percent of infants in each group developed IFALD (P = .94). However, infants in the group receiving 1 g/kg/d S-ILE (n = 20) had a lower rate of rise of DB compared with infants in the group receiving 2 g/kg/d S-ILE (n = 20).

Conclusions: Reducing S-ILE intake for 6 weeks in infants with GISD at ≥34 weeks' GA may not prevent IFALD. The extrapolated data on the rate of rise of DB suggest a possible risk of earlier development of IFALD with S-ILE intake of 2 g/kg/d, as compared with 1 g/kg/d, beyond the 6-week study period.