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

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.