Clinical evaluation of a novel preterm standardised parenteral nutrition system for targeted macronutrient delivery

BACKGROUND: System-based approaches to operationalise international nutrition recommendations for preterm infants do not exist. We developed the PremSmart (Preterm Standardised Multimodal and Responsive Transitional) nutrition system, comprising standardised parenteral nutrition (SPN) formulations and an enteral feed volume-based protocol using in silico modelling of macronutrient data to address this gap. This study evaluated the system's effectiveness in delivering macronutrient intakes within target ranges. METHODS: Prospectively collected macronutrient intake data from 49 infants ( < 34 wk gestation and ≤1500 g; n = 14 < 28 wk) who received the PremSmart system were compared with modelled intakes and predefined target ranges across two nutrition epochs: day of life 1-4 to evaluate incremental macronutrient advancement, and the transition phase, analysed across advancing enteral feed volumes (10 mL/kg/day increments). RESULTS: The system delivered amino acid, glucose and lipid intakes within target ranges across both nutrition epochs in <28wk and ≥28wk gestation subgroups, consistent with the modelled design. During days 1-4, median macronutrient intakes advanced incrementally within target ranges, and remained within target ranges throughout the transition phase. Overall daily amino acid target attainment was 88%, with no excessive intakes. SPN accounted for 97% of all parenteral nutrition days. CONCLUSIONS: Nutrient modelling enables data-informed SPN that achieves precise and safe macronutrient delivery. IMPACT: This is the first clinical study using modelling of historical macronutrient intake data to develop targeted standardised parenteral nutrition (SPN) products for preterm infants, addressing an unmet clinical need. It provides proof-of-concept evidence that a multimodal SPN system, comprising a starter and follow-on aqueous-SPN suite, an intravenous lipid emulsion, and an enteral feed volume-based protocol can achieve macronutrient delivery within predefined target ranges across the transition from parenteral to enteral nutrition in a diverse preterm cohort. Data-driven approaches such as nutrient modelling should be leveraged to design SPN for preterm infants capable of delivering precise nutrition and ensuring patient safety.