title: A double-blind randomised controlled trial of fish oil-based versus soy-based lipid preparations in the treatment of infants with parenteral nutrition-associated cholestasis.
abstract: BACKGROUND
  Infants receiving prolonged parenteral nutrition (PN) are at risk of PN-associated cholestasis (PNAC). This can progress to hepatic failure and death if PN cannot be discontinued. Fish oil-based parenteral lipid preparation (FOLP) has been shown to be beneficial in case studies.
  
  
  OBJECTIVE
  (1) To evaluate whether FOLP could halt or reverse the progression of PNAC compared with soy-based parenteral lipid preparation (SLP) and (2) to assess the effects of FOLP on liver function and physical growth.
  
  
  METHODS
  
  
  
  METHODS
  double-blind randomised controlled trial.
  
  
  METHODS
  level III neonatal intensive care unit.
  
  
  METHODS
  infants with PNAC (plasma-conjugated bilirubin concentration ≥ 34 µmol/l or 2 mg/dl) expected to be PN-dependent for >2 weeks.
  
  
  METHODS
  to receive either FOLP or SLP at 1.5 g/kg/day.
  
  
  METHODS
  reversal of PNAC within 4 months after commencement of lipid treatment; secondary outcomes: rate of change of weekly liver function tests, infant growth parameters, blood lipid profile and episodes of late-onset sepsis.
  
  
  RESULTS
  A total of 9 infants were randomised to the FOLP group and 7 to the SLP group. There was no significant difference in reversal of PNAC at 4 months between groups. Rates of increase of plasma-conjugated bilirubin and alanine aminotransferase in the SLP group were significantly greater than the FOLP group (13.5 vs. 0.6 µmol/l per week and 9.1 vs. 1.1 IU/l per week, respectively, p = 0.03). Increased enteral nutrition was associated with significant improvement of PNAC in infants receiving FOLP compared with SLP (-8.5 vs. -1.6 µmol/l per 10% increase in enteral nutrition, respectively). The study was terminated prematurely.
  
  
  CONCLUSIONS
  progression of PNAC in PN-dependent infants can be halted by replacing SLP with FOLP and reversed by increasing the proportion of enteral nutrition in infants receiving FOLP. Replacement of SLP with FOLP in PN-dependent infants who develop PNAC may be considered.
authors.affiliation: Department of Paediatrics, The Chinese University of Hong Kong, Prince of Wales Hospital, Sha Tin, Hong Kong.
authors.forename: Hugh S
authors.initials: HS
authors.lastname: Lam
authors.forename: Yuk H
authors.initials: YH
authors.lastname: Tam
authors.forename: Terence C W
authors.initials: TC
authors.lastname: Poon
authors.forename: Hon M
authors.initials: HM
authors.lastname: Cheung
authors.forename: Xinting
authors.initials: X
authors.lastname: Yu
authors.forename: Brenda P L
authors.initials: BP
authors.lastname: Chan
authors.forename: Kim H
authors.initials: KH
authors.lastname: Lee
authors.forename: Benjamin S C
authors.initials: BS
authors.lastname: Lee
authors.forename: Pak C
authors.initials: PC
authors.lastname: Ng
mesh_terms: D000410:Alanine Transaminase / Q000097:blood; D001663:Bilirubin / Q000097:blood; D015415:Biomarkers / Q000097:blood; D001724:Birth Weight; D002657:Child Development; D002779:Cholestasis / Q000097:blood / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D004311:Double-Blind Method; D057239:Early Termination of Clinical Trials; D004655:Emulsions / Q000008:administration & dosage; D004750:Enteral Nutrition; D005217:Fat Emulsions, Intravenous / Q000008:administration & dosage*; D005260:Female; D005395:Fish Oils / Q000008:administration & dosage*; D005865:Gestational Age; D006257:Head / Q000254:growth & development; D006723:Hong Kong; D006801:Humans; D007223:Infant; D007227:Infant Nutritional Physiological Phenomena; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007234:Infant, Premature; D007363:Intensive Care Units, Neonatal; D008099:Liver / Q000378:metabolism; D008297:Male; D009752:Nutritional Status; D010288:Parenteral Nutrition / Q000009:adverse effects*; D010743:Phospholipids / Q000008:administration & dosage*; D011446:Prospective Studies; D013024:Soybean Oil / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome; D014280:Triglycerides; D015430:Weight Gain
chemical_list: D015415:Biomarkers; D004655:Emulsions; D005217:Fat Emulsions, Intravenous; D005395:Fish Oils; D010743:Phospholipids; D014280:Triglycerides; C568345:fish oil triglycerides; C545823:soybean oil, phospholipid emulsion; D013024:Soybean Oil; D000410:Alanine Transaminase; D001663:Bilirubin