[en] OBJECTIVES: There is a concern that decreasing soybean oil (SO) content in intravenous lipid emulsions (ILEs) may increase the risk for essential fatty acid deficiency (EFAD). This study evaluates the risk of EFAD in pediatric patients who were expected to require parenteral nutrition for at least 7 days with an 80% olive oil/20% SO ILE (OO/SO group) versus a 100% SO ILE (SO group).
METHODS: This randomized, double-blind, controlled, multicenter study evaluated 101 pediatric patients including 94 preterm infants. The primary outcome was the incidence of EFAD, including the analysis of the plasma fatty acid (FA) profiles and genetic polymorphism in the FA desaturase genes in patients with extreme arachidonic acid values.
RESULTS: Treatment duration was 10.3 ± 7.8 and 11.3 ± 9.4 days in the OO/SO and SO groups respectively. No EFAD was observed. Linoleic acid values increased in both groups but to a lesser extent in the OO/SO group. Arachidonic acid values remained stable within the two groups. The changes in mead acid value were opposite in the two groups, demonstrating an increase in the OO/SO group and a decrease in the SO group, leading to similar changes in the triene:tetraene ratio (T:T). Genetic polymorphisms were frequently observed in patients presenting extreme arachidonic acid values in both groups.
CONCLUSIONS: The use of an 80% OO/20% SO ILE is well tolerated, safe, and does not increase the risk of EFAD in pediatric patients. The assessment of EFAD should not only consider the T:T but also the complete FA profile and genetic polymorphisms.
TRIAL IDENTIFICATION NUMBER: Trial Identification Number and URL: NCT04555044, https://clinicaltrials.gov/study/NCT04555044?term=NCT04555044&rank=1.
Disciplines :
Pediatrics
Author, co-author :
Blanco, Cynthia ; Division of Neonatology, University of Texas Health Science Center, San Antonio, Texas, USA
Chang, Weili; Division of Neonatology, East Carolina University Health Medical Center, Greenville, North Carolina, USA
Bhatt, Abhay J; Division of Neonatology, University of Mississippi Medical Center, Jackson, Mississippi, USA
Gerday, Erick; Division of Neonatology, Utah Valley Hospital, Provo, Utah, USA
Talati, Ajay J; Department of Pediatrics, The University of Tennessee Health Science Center, Memphis, Tennessee, USA
Dereddy, Narendra; Division of Neonatology, AdventHealth for Children, Orlando, Florida, USA
Singh, Rachana; Department of Pediatrics, Tufts University School of Medicine, Boston, Massachusetts, USA
Ryan, Erika; Baxter Healthcare Corporation, Deerfield, Illinois, USA
Senterre, Thibault ; Université de Liège - ULiège > Département des sciences de la santé publique ; Baxter Healthcare Corporation, Deerfield, Illinois, USA
Language :
English
Title :
Essential fatty acid deficiency, olive oil-based intravenous lipid emulsion, and genetic polymorphisms: A pediatric randomized controlled trial.
Publication date :
2025
Journal title :
Journal of Pediatric Gastroenterology and Nutrition
We thank all the participants, their family, and all the collaborators without whom this study would not have been completed, Julie Jakubowski, Surupa Sarkar, Alyssa Wilmington, and Clarissa Brincat for their valuable work on the study design, the statistics, and the medical writing. The study was sponsored by Baxter.
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