Use of Intravenous Soybean and Fish Oil Emulsions in Pediatric Intestinal Failure-Associated Liver Disease: A Multicenter Integrated Analysis Report on Extrahepatic Adverse Events

J Pediatr. 2022 Feb:241:173-180.e1. doi: 10.1016/j.jpeds.2021.10.030. Epub 2021 Oct 23.

Abstract

Objective: To compare extrahepatic adverse events during fish oil lipid emulsion (FOLE) or soybean oil lipid emulsion (SOLE) treatment in children with intestinal failure-associated liver disease (IFALD).

Study design: In this multicenter integrated analysis, bleeding, bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), infections, and signs of lipid emulsion intolerance were compared between FOLE recipients (1 g/kg/d) (n = 189) and historical controls who received SOLE (≤3 g/kg/d) (n = 73).

Results: When compared with SOLE recipients, FOLE recipients had a lower gestational age (30.5 vs 33.0 weeks; P = .0350) and higher baseline direct bilirubin (DB) (5.8 vs 3.0 mg/dL; P < .0001). FOLE recipients had a decreased incidence of bleeding (P < .0001), BPD (P < .001), ROP (P < .0156), bacterial and fungal infections (P < .0001), and lipid intolerance signs (P < .02 for all). Patients with bleeding vs patients without bleeding had higher baseline DB; the ORs for baseline DB (by mg/dL) and treatment (FOLE vs SOLE) were 1.20 (95% CI: 1.10, 1.31; P ≤ .0001) and 0.22 (95% CI: 0.11, 0.46; P ≤ .0001), respectively. In preterm infants, a higher BPD (P < .0001) and ROP incidence (P = .0071) was observed in SOLE recipients vs FOLE recipients.

Conclusions: Children with IFALD who received FOLE had fewer extrahepatic adverse events, including a decreased incidence of bleeding, preterm comorbidities, and lipid intolerance signs compared with children with IFALD who received SOLE. TRIAL REGISTRATION CLINICALTRIALS.GOV: NCT00910104 and NCT00738101.

Keywords: Omegaven; adverse events; intravenous lipid emulsion; safety; soybean oil.

Publication types

  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Fat Emulsions, Intravenous / adverse effects*
  • Fat Emulsions, Intravenous / therapeutic use
  • Female
  • Fish Oils / adverse effects*
  • Fish Oils / therapeutic use
  • Humans
  • Infant
  • Infant, Newborn
  • Intestinal Failure / complications
  • Intestinal Failure / therapy*
  • Liver Diseases / etiology*
  • Male
  • Parenteral Nutrition / adverse effects*
  • Parenteral Nutrition / methods
  • Retrospective Studies
  • Soybean Oil / adverse effects*
  • Soybean Oil / therapeutic use
  • Treatment Outcome

Substances

  • Fat Emulsions, Intravenous
  • Fish Oils
  • Soybean Oil

Associated data

  • ClinicalTrials.gov/NCT00910104
  • ClinicalTrials.gov/NCT00738101