Uthaya, S; Liu, X; Babalis, D; Doré, CJ; Warwick, J; Bell, J; Thomas, L; ... Modi, N; + view all Uthaya, S; Liu, X; Babalis, D; Doré, CJ; Warwick, J; Bell, J; Thomas, L; Ashby, D; Durighel, G; Ederies, A; Yanez-Lopez, M; Modi, N; - view fewer (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. 1443-1453. 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 compare1) 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 and2) 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 atwww.isrctn.comasISRCTN29665319and at eudract.ema.europa.eu as EudraCT 2009-016731-34.

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