Published online February 29, 2008
PEDIATRICS Vol. 121 No. 3 March 2008, pp. e678-e686 (doi:10.1542/peds.2007-2248)
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ARTICLE

Safety and Efficacy of a Fish-Oil–Based Fat Emulsion in the Treatment of Parenteral Nutrition–Associated Liver Disease

Kathleen M. Gura, PharmDa,b, Sang Lee, MDc, Clarissa Valim, MD, ScDb,c,d, Jing Zhou, MSd, Sendia Kim, MDc, Biren P. Modi, MDc, Danielle A. Arsenault, BSc, Robbert A. M. Strijbosch, BSc, Suzanne Lopes, RNe, Christopher Duggan, MD, MPHb and Mark Puder, MD, PhDc

a Departments of Pharmacy
b Division of Gastroenterology and Nutrition
c Surgery
d Clinical Research Program
e Department of Nursing, Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts

BACKGROUND. Parenteral nutrition–associated liver disease can be a progressive and fatal entity in children with short-bowel syndrome. Soybean-fat emulsions provided as part of standard parenteral nutrition may contribute to its pathophysiology.

METHODS. We compared safety and efficacy outcomes of a fish-oil–based fat emulsion in 18 infants with short-bowel syndrome who developed cholestasis (serum direct bilirubin level of >2 mg/dL) while receiving soybean emulsions with those from a historical cohort of 21 infants with short-bowel syndrome who also developed cholestasis while receiving soybean emulsions. The primary end point was time to reversal of cholestasis (3 consecutive measurements of serum direct bilirubin level of ≤2 mg/dL).

RESULTS. Among survivors, the median time to reversal of cholestasis was 9.4 and 44.1 weeks in the fish-oil and historical cohorts, respectively. Subjects who received fish-oil–based emulsion experienced reversal of cholestasis 4.8 times faster than those who received soybean emulsions and 6.8 times faster in analysis adjusted for baseline bilirubin concentration, gestational age, and the diagnosis of necrotizing enterocolitis. A total of 2 deaths and 0 liver transplantations were recorded in the fish-oil cohort and 7 deaths and 2 transplantations in the historical cohort. The provision of fish-oil–based fat emulsion was not associated with essential fatty acid deficiency, hypertriglyceridemia, coagulopathy, infections, or growth delay.

CONCLUSIONS. Parenteral fish-oil–based fat emulsions are safe and may be effective in the treatment of parenteral nutrition–associated liver disease.

Key Words: {omega}-3 • cholestasis • parenteral nutrition associated liver disease • fish oil • parenteral nutrition

Abbreviations: PN—parenteral nutrition • PNALD—parenteral nutrition–associated liver disease • EN—enteral nutrition • CHB—Children's Hospital Boston • SBS—short-bowel syndrome • IQR—interquartile range • CI—confidence interval

Accepted Oct 24, 2007.