title: Effect of decreased parenteral soybean lipid emulsion on hepatic function in infants at risk for parenteral nutrition-associated liver disease: a pilot study.
abstract: OBJECTIVE
  We performed a pilot trial to compare reduced dose versus standard soybean lipid emulsion in neonates at risk for parenteral nutrition-associated liver disease.
  
  
  METHODS
  A prospective randomized controlled trial was performed (2009-2011) enrolling surgical patients ≥ 26 weeks' gestation anticipated to require >50% of daily caloric intake from parenteral nutrition (PN) for at least 4 weeks. Randomization occurred into either reduced (1.0 g/kg/day) or standard (3g/kg/day) groups. Co-primary outcomes for interpretation of the results were conjugated bilirubin and total bile acids. Additional outcomes included ALT, AST, GGT, alkaline phosphatase, growth, and essential fatty acid levels. Outcomes were compared between treatment groups using Wilcoxon rank sums tests.
  
  
  RESULTS
  Twenty-eight patients (47% enrollment rate) were included in the study with an average treatment duration of 5.4 weeks. Groups had similar PN calories and protein intake throughout the study. Total increase from baseline was smaller in the reduced vs. standard group for conjugated bilirubin (p=0.04) and total bile acids (p=0.02). Weight z-score increased more in the standard group, and no patient experienced essential fatty acid deficiency.
  
  
  CONCLUSIONS
  Markers of cholestasis rose at a slower rate using reduced lipid doses. This pilot study demonstrates feasibility and need for a larger study evaluating the effects of reduced lipids in patients at risk for developing parenteral nutrition-associated liver disease.
authors.affiliation: Division of Pediatric Surgery, Primary Children's Medical Center, University of Utah, Salt Lake City, UT 84113-1103, USA. michael.rollins@imail.org
authors.forename: Michael D
authors.initials: MD
authors.lastname: Rollins
authors.forename: Robert M
authors.initials: RM
authors.lastname: Ward
authors.forename: W Daniel
authors.initials: WD
authors.lastname: Jackson
authors.forename: Cecilia W
authors.initials: CW
authors.lastname: Mulroy
authors.forename: Cindy P
authors.initials: CP
authors.lastname: Spencer
authors.forename: Jian
authors.initials: J
authors.lastname: Ying
authors.forename: Tom
authors.initials: T
authors.lastname: Greene
authors.forename: Linda S
authors.initials: LS
authors.lastname: Book
mesh_terms: D015415:Biomarkers / Q000097:blood; D002779:Cholestasis / Q000097:blood / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D005217:Fat Emulsions, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects; D005240:Feasibility Studies; D005500:Follow-Up Studies; D020139:Gastroschisis / Q000628:therapy; D048550:Hepatic Insufficiency / Q000097:blood / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007410:Intestinal Diseases / Q000601:surgery; D008111:Liver Function Tests; D010288:Parenteral Nutrition / Q000009:adverse effects / Q000379:methods*; D010865:Pilot Projects; D011182:Postoperative Care / Q000009:adverse effects / Q000379:methods; D011446:Prospective Studies; D013024:Soybean Oil / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D005217:Fat Emulsions, Intravenous; D013024:Soybean Oil
keywords: Cholestasis; Parenteral nutrition; Parenteral nutrition-associated liver disease; Randomized controlled trial