Practical handling, ease of use, safety, and efficacy of a new pediatric triple-chamber bag for parenteral nutrition in preterm infants

Rationale: The objective of this study was to evaluate the first ready to use multi-chamber parenteral nutrition (PN) system, Ped3CB-A 300 mL, with optional lipid bag activation, specially designed for preterm infants. Methods: Preterm requiring 80% of their total estimated nutritional needs as PN were included in a prospective, open-label, multicenter, noncomparative, Phase III clinical trial for 5 -10 consecutive days. PN intakes, additional PN intakes, oral intakes, body weight and adverse events were collected daily during the study. Results: 113 infants were enrolled in the study and 97 (BW: 1382±520 g, GA: 31.2±2.5 weeks, PNA: 5.6±6.1 d) were included in the per protocol analysis accounting for 854 perfusion days. 32 PN infusion days in 11 infants involved double-chamber bag activation. Vitamins and trace elements were provided to 100% and 96% of the infants respestively. 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 PN intakes during the study and maximum daily parenteral nutrient intakes in each infants were 2.8±0.7 and 3.6±0.8 g AA/kg d and 80±20 and 104±22 kcal/kg d within the actual recommended ranges for this population. Mean weight gain represented 10.0, 21.5 and 22.6 g/kg d according to age at inclusion, 0 3, 4 7 and >7 days of life. No adverse events were attributable to the design of the Ped3CB-A system. Conclusion: Ped3CB-A provides ease of use, well balanced and safe nutritional support; has the flexibility required to meet the varied and changing nutritional needs of preterm infants and provides levels of nutrients within the ranges of recent recommendations.