title: A comparison of 2 intravenous lipid emulsions: interim analysis of a randomized controlled trial.
abstract: OBJECTIVE
  To assess the safety and efficacy of a fish oil-based intravenous fat emulsion (FIFE) in reducing the incidence of cholestasis in neonates compared with the traditional soybean oil-based intravenous fat emulsion (SIFE).
  
  
  METHODS
  A double-blind randomized controlled trial was conducted. Nineteen neonates were enrolled (10 SIFE; 9 FIFE). Nutrition assessments and laboratory studies were serially obtained for the duration of PN support or until 6 months' corrected gestational age. Neurodevelopmental outcomes were assessed at 6 and 24 months' corrected age.
  
  
  RESULTS
  There were no differences between groups in demographic characteristics, with an overall median age of 2 days, gestational age of 36 weeks, and birth weight of 2410 g. There were no differences between groups in baseline laboratory values other than alkaline phosphatase (lower in the FIFE group) or in the duration of parenteral nutrition (PN), amount of enteral intake, or the number of operative procedures. The incidence of cholestasis among enrolled patients was significantly lower than expected, resulting in early study termination and an inability to assess for differences in the incidence of cholestasis. The FIFE was associated with no increased risk of growth impairment, coagulopathy, infectious complications, hypertriglyceridemia, or adverse neurodevelopmental outcomes. No patient developed essential fatty acid deficiency.
  
  
  CONCLUSIONS
  The FIFE at 1 g/kg/d was well tolerated in the neonates recruited for this study. Given the necessary early termination of this study, a follow-up trial with revised eligibility criteria is necessary to determine whether the provision of FIFE decreases the incidence of PN-cholestasis compared with the traditional SIFE.
authors.affiliation: Department of Surgery and the Vascular Biology Program, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Deepika
authors.initials: D
authors.lastname: Nehra
authors.affiliation: Department of Surgery and the Vascular Biology Program, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Erica M
authors.initials: EM
authors.lastname: Fallon
authors.affiliation: Department of Surgery and the Vascular Biology Program, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Alexis K
authors.initials: AK
authors.lastname: Potemkin
authors.affiliation: Department of Radiology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Stephan D
authors.initials: SD
authors.lastname: Voss
authors.affiliation: Department of Statistics and the Clinical Research Program, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Paul D
authors.initials: PD
authors.lastname: Mitchell
authors.affiliation: Department of Statistics and the Clinical Research Program, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Clarissa
authors.initials: C
authors.lastname: Valim
authors.affiliation: Division of Newborn Medicine, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Mandy B
authors.initials: MB
authors.lastname: Belfort
authors.affiliation: Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: David C
authors.initials: DC
authors.lastname: Bellinger
authors.affiliation: Division of Gastroenterology/Nutrition, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Christopher
authors.initials: C
authors.lastname: Duggan
authors.affiliation: Department of Pharmacy, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Gura
authors.affiliation: Department of Surgery and the Vascular Biology Program, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts mark.puder@childrens.harvard.edu.
authors.forename: Mark
authors.initials: M
authors.lastname: Puder
mesh_terms: D001724:Birth Weight; D002779:Cholestasis / Q000517:prevention & control*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005217:Fat Emulsions, Intravenous / Q000627:therapeutic use*; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage / Q000032:analysis; D005260:Female; D005395:Fish Oils / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010288:Parenteral Nutrition; D012307:Risk Factors; D013024:Soybean Oil / Q000627:therapeutic use*; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
chemical_list: D005217:Fat Emulsions, Intravenous; D015525:Fatty Acids, Omega-3; D005395:Fish Oils; D014280:Triglycerides; D013024:Soybean Oil
keywords: cholestasis; fatty acid; fish oil; lipid emulsion; neonatal; parenteral nutrition; parenteral nutrition–associated liver disease; soybean oil; ω-3; ω-6