title: Low-Dose Parenteral Soybean Oil for the Prevention of Parenteral Nutrition-Associated Liver Disease in Neonates With Gastrointestinal Disorders.
abstract: Neonates with gastrointestinal disorders (GDs) are at high risk for parenteral nutrition-associated liver disease (PNALD). Soybean-based intravenous lipid emulsions (S-ILE) have been associated with PNALD. This study's objective was to determine if a lower dose compared with a higher dose of S-ILE prevents cholestasis without compromising growth.
  
  
  
  This multicenter randomized controlled pilot study enrolled patients with GDs who were ≤5 days of age to a low dose (~1 g/kg/d) (LOW) or control dose of S-ILE (~3 g/kg/d) (CON). The primary outcome was cholestasis (direct bilirubin [DB] >2 mg/dL) after the first 7 days of age. Secondary outcomes included growth, PN duration, and late-onset sepsis.
  
  
  
  Baseline characteristics were similar between the LOW (n = 20) and CON groups (n = 16). When the LOW group was compared with the CON group, there was no difference in cholestasis (30% vs 38%, P = .7) or secondary outcomes. However, mean ± SE DB rate of change over the first 8 weeks (0.07 ± 0.04 vs 0.3 ± 0.09 mg/dL/wk, P = .01) and entire study (0.008 ± 0.03 vs 0.2 ± 0.07 mg/dL/wk, P = .02) was lower in the LOW group compared with the CON group.
  
  
  
  In neonates with GDs who received a lower dose of S-ILE, DB increased at a slower rate in comparison to neonates who received a higher dose of S-ILE. Growth was comparable between the groups. This study demonstrates a need for a larger, randomized controlled trial comparing 2 different S-ILE doses for cholestasis prevention in neonates at risk for PNALD.
authors.affiliation: 1 David Geffen School of Medicine, University of California, Los Angeles, and Mattel Children's Hospital at UCLA, Department of Pediatrics, Division of Neonatology and Developmental Biology, Neonatal Research Center of the UCLA Children's Discovery and Innovation Institute, Los Angeles, California, USA.
authors.forename: Kara L
authors.initials: KL
authors.lastname: Calkins
authors.affiliation: 2 Department of Pediatrics, Division of Neonatology, St Louis University School of Medicine, Cardinal Glennon Children's Hospital, St Louis, Missouri, USA.|3 Department of Pediatrics, Division of Neonatology, Albert Einstein College of Medicine, Bronx, New York, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Havranek
authors.affiliation: 4 Department of Surgery, Division of General Surgery, David Geffen School of Medicine, University of California, Los Angeles, California, USA.
authors.forename: Lorraine I
authors.initials: LI
authors.lastname: Kelley-Quon
authors.affiliation: 2 Department of Pediatrics, Division of Neonatology, St Louis University School of Medicine, Cardinal Glennon Children's Hospital, St Louis, Missouri, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Cerny
authors.affiliation: 5 Department of Biostatistics, Fielding School of Public Health, University of California, Los Angeles, California, USA.
authors.forename: Martiniano
authors.initials: M
authors.lastname: Flores
authors.affiliation: 6 Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, California, USA.
authors.forename: Tristan
authors.initials: T
authors.lastname: Grogan
authors.affiliation: 7 Department of Surgery, Division of Pediatric Surgery, David Geffen School of Medicine, University of California, Los Angeles, California, USA.
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Shew
mesh_terms: D001663:Bilirubin / Q000097:blood; D002779:Cholestasis / Q000097:blood / Q000209:etiology / Q000517:prevention & control; D004305:Dose-Response Relationship, Drug; D005217:Fat Emulsions, Intravenous / Q000737:chemistry; D005240:Feasibility Studies; D005260:Female; D005767:Gastrointestinal Diseases / Q000150:complications / Q000628:therapy*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008107:Liver Diseases / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D010288:Parenteral Nutrition / Q000009:adverse effects*; D010865:Pilot Projects; D013024:Soybean Oil / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D005217:Fat Emulsions, Intravenous; D013024:Soybean Oil; D001663:Bilirubin
keywords: cholestasis; gastrointestinal disorders; neonates; parenteral nutrition; soybean oil