title: Low-Dose Intravenous Soybean Oil Emulsion for Prevention of Cholestasis in Preterm Neonates.
abstract: BACKGROUND
  Premature infants depend on intravenous fat emulsions to supply essential fatty acids and calories. The dose of soybean-based intravenous fat emulsions (S-IFE) has been associated with parenteral nutrition (PN)-associated liver disease. This study's purpose was to determine if low-dose S-IFE is a safe and effective preventive strategy for cholestasis in preterm neonates.
  
  
  METHODS
  This is a multicenter randomized controlled trial in infants with a gestational age (GA) ≤29 weeks. Patients <48 hours of life were randomized to receive a low (1 g/kg/d) or control dose (approximately 3 g/kg/d) of S-IFE. The primary outcome was cholestasis, defined as a direct bilirubin ≥15% of the total bilirubin at 28 days of life (DOL) or full enteral feeds, whichever was later, after 14 days of PN. Secondary outcomes included growth, length of hospital stay, death, and major neonatal morbidities.
  
  
  RESULTS
  In total, 136 neonates (67 and 69 in the low and control groups, respectively) were enrolled. Baseline characteristics were similar for the 2 groups. When the low group was compared with the control group, there was no difference in the primary outcome (69% vs 63%; 95% confidence interval, -0.1 to 0.22; P = .45). While the low group received less S-IFE and total calories over time compared with the control group (P < .001 and P = .03, respectively), weight, length, and head circumference at 28 DOL, discharge, and over time were not different (P > .2 for all).
  
  
  CONCLUSIONS
  Compared with the control dose, low-dose S-IFE was not associated with a reduction in cholestasis or growth.
authors: Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut orly.levit@yale.edu.
authors: Orly L
authors: OL
authors: Levit
authors: Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, California.
authors: Kara L
authors: KL
authors: Calkins
authors: Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, California.
authors: L Caroline
authors: LC
authors: Gibson
authors: Department of Surgery, David Geffen School of Medicine, University of California, Los Angeles, California.
authors: Lorraine
authors: L
authors: Kelley-Quon
authors: Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors: Daniel T
authors: DT
authors: Robinson
authors: Department of Medicine Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, California.
authors: David A
authors: DA
authors: Elashoff
authors: Department of Medicine Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, California.
authors: Tristan R
authors: TR
authors: Grogan
authors: Department of Biomathematics, University of California, Los Angeles, California.
authors: Ning
authors: N
authors: Li
authors: Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut.
authors: Matthew J
authors: MJ
authors: Bizzarro
authors: Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut.
authors: Richard A
authors: RA
authors: Ehrenkranz
mesh_terms: D061605:Administration, Intravenous; D001663:Bilirubin / Q000378:metabolism; D002779:Cholestasis / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D005217:Fat Emulsions, Intravenous / Q000008:administration & dosage*; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature / Q000254:growth & development*; D007902:Length of Stay; D013024:Soybean Oil / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D005217:Fat Emulsions, Intravenous; D013024:Soybean Oil; D001663:Bilirubin
keywords: growth; parenteral nutrition–associated liver disease; prematurity