Objectives: The aim of this study was to evaluate the efficacy, safety, flexibility, and ease of handling and use of the Ped3CB-A 300 mL, the first ready-to-use multichamber parenteral nutrition (PN) system, with optional lipid bag activation, specially designed for administration to preterm infants.
Materials and Methods: In this prospective, open-label, multicenter, noncomparative, phase III clinical trial, preterm infants were treated with Ped3CB-A for 5 to 10 consecutive days.
Results: A total of 113 preterm infants were enrolled in the study and 97 (birth weight 1382 ± 520 g; gestational age 31.2 ± 2.5 weeks; postnatal age administration 5.6 ± 6.1 days) were included in the per protocol analysis accounting for 854 perfusion days. Double-chamber bag activation was used for 32 perfusion days. Macronutrient, electrolyte, and mineral supplements were primarily administered through a Y-line or directly in the activated bag. In all, 199 additions (mainly sodium, 95%) were made to the Ped3CB-A bags on 197 infusion days (23.1%) in 43 infants (44.3%). More than 1 of these nutrients was added to the bag on only 1 perfusion day. Mean and maximum parenteral nutrient intakes were 2.8 ± 0.7 and 3.6 ± 0.8 g amino acids per kilogram per day, and 80 ± 20 and 104 ± 22 kcal · kg−1 · day−1. Mean weight gain represented 10.0, 21.5, and 22.6 g · kg−1 · day−1 according to age at inclusion (0–3, 4–7, or >7 days of life). A visual analog scale was completed and produced positive results. No adverse events were attributable to the design of the Ped3CB-A system.
Conclusions: Ped3CB-A provides easy-to-use, well-balanced, and safe nutritional support. Nutritional intakes and weight gain were within the recent PN recommendations in preterm infants.