Uthaya, Sabita, Liu, Xinxue, Babalis, Daphne, Dore, Caroline, Warwick, Jane, Bell, Jimmy, Thomas, Louise, Ashby, Deborah, Durighel, Giuliana, Ederies, Ash, Yanez-Lopez, Monica and Modi, Neena (2016) Nutritional evaluation and optimisation in neonates : a randomized, double-blind controlled trial of amino acid regimen and intravenous lipid composition in preterm parenteral nutrition. American Journal of Clinical Nutrition, 103 (6). pp. 1443-1452. doi:10.3945/ajcn.115.125138

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Abstract

Background:
Parenteral nutrition is central to the care of very immature infants. Current international recommendations favor higher amino acid intakes and fish oil–containing lipid emulsions.

Objective:
The aim of this trial was to compare 1) the effects of high [immediate recommended daily intake (Imm-RDI)] and low [incremental introduction of amino acids (Inc-AAs)] parenteral amino acid delivery within 24 h of birth on body composition and 2) the effect of a multicomponent lipid emulsion containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil (SMOF) with that of soybean oil (SO)-based lipid emulsion on intrahepatocellular lipid (IHCL) content.

Design:
We conducted a 2-by-2 factorial, double-blind, multicenter randomized controlled trial.

Results:
We randomly assigned 168 infants born at <31 wk of gestation. We evaluated outcomes at term in 133 infants. There were no significant differences between Imm-RDI and Inc-AA groups for nonadipose mass [adjusted mean difference: 1.0 g (95% CI: −108, 111 g; P = 0.98)] or between SMOF and SO groups for IHCL [adjusted mean SMOF:SO ratio: 1.1 (95% CI: 0.8, 1.6; P = 0.58]. SMOF does not affect IHCL content. There was a significant interaction (P = 0.05) between the 2 interventions for nonadipose mass. There were no significant interactions between group differences for either primary outcome measure after adjusting for additional confounders. Imm-RDI infants were more likely than Inc-AA infants to have blood urea nitrogen concentrations >7 mmol/L or >10 mmol/L, respectively (75% compared with 49%, P < 0.01; 49% compared with 18%, P < 0.01). Head circumference at term was smaller in the Imm-RDI group [mean difference: −0.8 cm (95% CI: −1.5, −0.1 cm; P = 0.02)]. There were no significant differences in any prespecified secondary outcomes, including adiposity, liver function tests, incidence of conjugated hyperbilirubinemia, weight, length, mortality, and brain volumes.

Conclusion:
Imm-RDI of parenteral amino acids does not benefit body composition or growth to term and may be harmful. This trial was registered at www.isrctn.com as ISRCTN29665319 and at eudract.ema.europa.eu as EudraCT 2009-016731-34.

Item Type:	Journal Article
Subjects:	R Medicine > RJ Pediatrics
Divisions:	Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Premature infants, Fat emulsions, Intravenous, Parenteral therapy, Clinical trials
Journal or Publication Title:	American Journal of Clinical Nutrition
Publisher:	American Society for Nutrition
ISSN:	0002-9165
Official Date:	1 June 2016
Dates:	Date Event 1 June 2016 Published 20 April 2016 Available 24 March 2016 Accepted 9 October 2015 Submitted
Date of first compliant deposit:	27 April 2016
Volume:	103
Number:	6
Number of Pages:	10
Page Range:	pp. 1443-1452
DOI:	10.3945/ajcn.115.125138
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
Funder:	Medical Research Council (Great Britain) (MRC), National Institute for Health Research (Great Britain) (NIHR)
Grant number:	08/99/04 (NIHR)

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