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A secondary Outcome Analysis of a Randomized Trial Using a Mixed Lipid Emulsion Containing Fish Oil in Infants with Extremely Low Birth Weight: Cognitive and Behavioral Outcome at Preschool Age - 14/03/23

Doi : 10.1016/j.jpeds.2022.10.014 
Margarita Thanhaeuser, MD 1, , David Steyrl, PhD 2, Renate Fuiko, PhD 1, Sophia Brandstaetter, MD 1, Christoph Binder, PhD 1, Alexandra Thajer, PhD, PhD, MBA 1, Mercedes Huber-Dangl, MD 1, Nadja Haiden, MD, MSc 3, Angelika Berger, MD, MBA 1, Andreas Repa, MD 1
1 Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Department of Pediatrics and Adolescent Medicine, Comprehensive Center for Pediatrics, Medical University of Vienna, Vienna, Austria 
2 Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria 
3 Department of Clinical Pharmacology, Medical University of Vienna, Austria 

Reprint requests: Margarita Thanhaeuser, MD, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.Department of Pediatrics and Adolescent MedicineMedical University of ViennaWaehringer Guertel 18-20Vienna1090Austria

Abstract

Objective

To evaluate the impact of a parenteral lipid emulsion containing fish oil compared with a soybean oil based-lipid emulsion on the cognitive outcome and behavior of preschool children with extremely low birth weight.

Study design

This was a retrospective secondary outcome analysis of a randomized controlled trial performed between June 2012 and June 2015. Infants with extremely low birth weight received either a mixed (soybean oil, medium chain triglycerides, olive oil, fish oil) or a soybean oil-based lipid emulsion for parenteral nutrition. Data from the Kaufman Assessment Battery for Children II, the Child Behavior Checklist 1.5-5, and anthropometry were collected from medical charts at 5.6 years of age.

Results

At discharge, 206 of the 230 study participants were eligible. At 5 years 6 months of age, data of 153 of 206 infants (74%) were available for analysis. There were no significant differences in Kaufman Assessment Battery for Children II scores for Sequential/Gsm, Simultaneous/Gv, Learning/Glr, and Mental Processing Index (mixed lipid: median, 97.5 [IQR, 23.5]; soybean oil: median, 96 [IQR, 19.5]; P = .43) or Child Behavior Checklist 1.5-5 scores for internalizing problems, externalizing problems, or total problems (mixed lipid: median, 37 [IQR, 12.3]; soybean oil: median, 37 [IQR, 13.5]; P = .54).

Conclusions

A RandomForest machine learning regression analysis did not show an effect of type of lipid emulsion on cognitive and behavioral outcome. Parenteral nutrition using a mixed lipid emulsion containing fish oil did not affect neurodevelopment and had no impact on child behavior of infants with extremely low birth weights at preschool age.

Trial registration

ClinicalTrials.gov: NCT01585935.

Le texte complet de cet article est disponible en PDF.

Keywords : neurodevelopmental outcome, fish oil, parenteral nutrition, premature infant

Abbreviations∗∗∗ : ARA, ASD, CBCL 1.5-5, DHA, ELBW, KABC II, PUFA


Plan


 Funded by the Austrian Science Fund (FWF, KLI99-B00). Study emulsions were provided free of charge by Herba Chemosan (Graz, Austria). Fresenius Kabi (Graz, Austria) provided funding to employ a clinical research nurse. The companies had no role in the study, in particular concerning design, analysis, interpretation or reporting of results and preparation of the manuscript. A.R. received a research grant by Fresenius Kabi (Graz, Austria). The company had no role in the study, in particular concerning design, analysis, interpretation or reporting of results and preparation of the manuscript. The other authors declare no conflicts of interest.


© 2022  The Author(s). Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 254

P. 68 - mars 2023 Retour au numéro
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