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Nutritional Evaluation and Optimisation in Neonates (NEON): a Randomised Double-Blind Controlled Trial of Amino-Acid Regimen and Intravenous Lipid Composition in Preterm Parenteral Nutrition

Presented at the Neonatal Society 2015 Summer Meeting.

Uthaya S1,2, Liu X3, Babalis D3,4, Doré CJ5, Warwick J3, Bell J6, Thomas L6, Ashby D2, Durighel G6, Ederies A7, Yanez-Lopez M4, Modi N1,2

1 Chelsea and Westminster NHS Foundation Trust, London, UK
2 Section of Neonatal Medicine, Department of Medicine, Imperial College London, London, UK
3 Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK
4 Clinical Trials and Evaluation Unit, Royal Brompton and Harefield NHS Foundation Trust, London, UK
5 Comprehensive Clinical Trials Unit, University College London, London, UK
6 Department of Life Sciences, University of Westminster, London, UK
7 Institute of Clinical Sciences, Imperial College London and MRC Clinical Sciences Centre, Hammersmith Hospital, London, UK

Background: Parenteral nutrition is central to the care of very immature infants. There is continuing uncertainty regarding optimal amino-acid intakes and intravenous lipid formulations. High amino-acid regimens and fish oil-containing lipid emulsions have been advocated.

Methods: We conducted a two-by-two factorial, double-blind multi-centre randomised controlled trial comparing the effect of immediate delivery of current Recommended Daily Intake of parenteral amino-acids (Imm-RDI) versus incremental introduction (Inc-AA) on body composition, and SMOFlipid versus Intralipid on Intra-Hepato-Cellular Lipid (IHCL). We commenced trial interventions and milk feeds within 24 hours of birth. The trial was pre-registered (ISRCTN29665319; EudraCT: 2009-016731-34) and approved by the UK National Research Ethics Service and Medicines and Healthcare and products Regulatory Agency. The trial sponsor was Imperial College London and was funded by the Efficacy and Mechanism Progamme of the National Institute of Health Research.

Results: We randomised 168 infants <31 weeks gestation. We evaluated outcomes at term in 133 infants. There were no significant differences between Imm-RDI and Inc-AA on non-adipose mass (adjusted mean difference; 95% CI: 1.0g; -108, 111) or between SMOFlipid and Intralipid on IHCL (adjusted mean ratio SMOFlipid:Intralipid; 95% CI: 1.1; 0.8, 1.6). Imm-RDI infants were more likely than Inc-AA to have blood urea nitrogen levels greater than 7mmol/l (75% vs 49%; p<0.01) and 10mmol/l (49% vs 18%; p<0.01) and a smaller head circumference at term (-0.8cm; -1.5, -0.1; p= 0.02). There were no significant differences in any other pre-specified secondary outcomes including adiposity, liver function tests, weight, length or mortality.

Conclusion: Immediate delivery of RDI of parenteral amino-acids does not benefit body composition or growth to term and may be harmful; SMOFLipid does not reduce IHCL. High amino-acid intakes should be used with caution in very preterm neonates and only in the context of randomised controlled trials.

Corresponding author: s.uthaya@imperial.ac.uk

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