Comparison of Two Lipid Emulsions on the Incidence of Parenteral Nutrition Associated Cholestasis in Neonates

Joy Greenberg; Mamta Naik; John Chapman; Allison Davidson; Essam Imseis

doi:10.5863/1551-6776-28.2.129

Comparison of Two Lipid Emulsions on the Incidence of Parenteral Nutrition Associated Cholestasis in Neonates

J Pediatr Pharmacol Ther. 2023;28(2):129-135. doi: 10.5863/1551-6776-28.2.129. Epub 2023 Apr 26.

Authors

Joy Greenberg¹, Mamta Naik¹, John Chapman², Allison Davidson², Essam Imseis³

Affiliations

¹ Department of Pharmacy Services (JG, MN), Children's Memorial Hermann Hospital, Texas Medical Center, Houston, TX.
² Department of Pediatrics (JC, AD), Division of Neonatal-Perinatal Medicine, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.
³ Department of Pediatrics (EI), Division of Pediatric Gastroenterology, Hepatology and Nutrition, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.

Abstract

Objective: Lipid emulsion contributes to parenteral nutrition associated cholestasis (PNAC). For decades, soybean oil-based intravenous lipid emulsion (SO-ILE) was the predominant product. Recently, a multicomponent lipid emulsion containing soybean oil, medium-chain triglycerides, olive oil and fish oil (SMOF-ILE) has been used off-label in neonatal care. This study evaluates the incidence of PNAC in neonates who received SMOF-ILE or SO-ILE.

Methods: This was a retrospective review of neonates who received SMOF-ILE or SO-ILE for at least 14 days. Patients receiving SMOF-ILE were matched based on gestational age (GA) and birth weight to a historical cohort receiving SO-ILE. The primary outcomes were the incidences of PNAC among all patients and patients without intestinal failure. The secondary outcomes were clinical outcomes and incidence of PNAC stratified by GA. Clinical outcomes included liver function tests, growth parameters, and development of retinopathy of prematurity and intraventricular hemorrhage.

Results: Forty-three neonates who received SMOF-ILE were matched to 43 neonates who received SOILE. There were no significant differences in baseline characteristics. The incidence of PNAC in the total population was 12% in the SMOF-ILE cohort and 23% in the SO-ILE cohort (p = 0.26). The lipid dosage of SMOF-ILE was significantly higher at time of peak direct serum bilirubin concentration compared with SO-ILE cohort (p = 0.05). Clinically significant differences were noted in laboratory endpoints in several subgroups.

Conclusions: There was no significant difference in the incidence of PNAC among neonates in a SMOFILE cohort compared with a historical SO-ILE cohort.

Keywords: cholestasis; intravenous fat emulsions; lipid emulsion; neonate; parenteral nutrition.