Developmental outcomes after soybean oil vs mixed-oil intravenous lipid emulsions in neonates: A secondary analysis of a clinical trial
Developmental outcomes after soybean oil vs mixed-oil intravenous lipid emulsions in neonates: A secondary analysis of a clinical trial

Developmental outcomes after soybean oil vs mixed-oil intravenous lipid emulsions in neonates: A secondary analysis of a clinical trial

JPEN J Parenter Enteral Nutr. 2025 Nov 10. doi: 10.1002/jpen.70032. Online ahead of print.

ABSTRACT

BACKGROUND: Fatty acids make up a significant portion of brain mass. The choice of lipid injectable emulsion alters a patient’s fatty acid profile. In neonates with intestinal failure dependent on parenteral nutrition, this is particularly concerning given their rapid brain development.

METHODS: We randomly assigned 24 infants to receive soy oil lipid emulsion at 1 g/kg/day or mixed-oil lipid emulsion containing soy, medium-chain triglyceride, olive, and fish oils at 3 g/kg/day. We have previously reported data on intestinal failure-associated liver disease incidence with a 39-day median follow-up. We now report 3-year follow-up, nonprespecified neurodevelopmental screening outcomes using the Ages & Stages Questionnaires-3, a test composed of five domains.

RESULTS: For this follow-up analysis, 20 patients were included, 10 in each group. There was no difference in patient parameters between the groups at birth or screening. The mean ± SD peak direct bilirubin was not different between the two groups (soy 1.8 ± 1.4 mg/dl and mixed 1.2 ± 0.8 mg/dl; P = 0.265). There was also no difference when comparing the mean scores or rate of developmental delay for all five Ages & Stages Questionnaire-3 domains between treatment groups. There was no correlation between peak direct bilirubin, gestational age, or days of lipid and domain scores.

CONCLUSION: In this follow-up study of children who had previously received soy oil lipid reduction or a mixed lipid, there was no difference in development at 3 years. Given that this is a secondary outcome from a pilot trial, additional studies powered for developmental differences are warranted.

PMID:41214458 | DOI:10.1002/jpen.70032