High rates of resolution of cholestasis in parenteral nutrition-associated liver disease with fish oil-based lipid emulsion monotherapy

J Pediatr. 2013 Apr;162(4):793-798.e1. doi: 10.1016/j.jpeds.2012.10.019. Epub 2012 Nov 16.


Objective: To determine factors leading to resolution of cholestasis in patients with parenteral nutrition-associated liver disease treated with fish oil-based lipid emulsion (FOLE).

Study design: Prospective observational study of 57 infants <6 months of age with parenteral nutrition-associated liver disease who received parenteral FOLE as monotherapy.

Results: Median gestational age of subjects at birth was 28 weeks (range 22.7-39.5). Median conjugated bilirubin level at initiation of therapy with FOLE was 7.5 mg/dL (range 2.1-25). Resolution of hyperbilirubinemia (conjugated bilirubin <2.0 mg/dL) and survival to hospital discharge occurred in 47 (82.5%) infants. Median number of days to resolution of cholestasis was 35 (range 7-129). Ten infants (17.5%) died. Non-survivors showed a trend towards being more premature than survivors at birth (25.9 vs 29.1 weeks, P = .056). Infants with higher conjugated bilirubin at initiation of therapy (>10.0 compared with <5.0 mg/dL) had longer times to resolution (98 vs 56 days, P < .005). Time to resolution correlated inversely with gestational age at birth (r(2) = 0.14, P = .02) and directly with time to receive 100% calories enterally (r(2) = 0.12, P = .03).

Conclusions: Younger gestational age infants demonstrated higher degree of cholestasis, longer time to resolution of cholestasis, and increased mortality. Higher levels of cholestasis were associated with longer time to resolution. FOLE monotherapy led to resolution of cholestasis in all surviving infants.

Trial registration: ClinicalTrials.gov NCT00738101.

MeSH terms

  • Cholestasis / etiology*
  • Cholestasis / therapy*
  • Fat Emulsions, Intravenous / administration & dosage
  • Female
  • Fish Oils
  • Humans
  • Hyperbilirubinemia / complications
  • Hyperbilirubinemia / therapy
  • Infant
  • Infant, Newborn
  • Lipids / chemistry
  • Liver Diseases / etiology*
  • Liver Diseases / therapy*
  • Male
  • Parenteral Nutrition / adverse effects*
  • Prospective Studies
  • Risk
  • Treatment Outcome


  • Fat Emulsions, Intravenous
  • Fish Oils
  • Lipids

Associated data

  • ClinicalTrials.gov/NCT00738101