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.
*Department of Paediatrics, Neonatal Unit, University of Liege, Belgium
†Baxter Healthcare, Deerfield, IL
‡Baxter SAS, Maurepas
§Paris Descartes University, APHP Necker Hospital, Paris, France
||Maternité Régionale Adolphe Pinard, Service Néonatologie-Soins Intensifs et Réanimation Néonatale-Génétique, Nancy
¶Service de Réanimation Néonatale, CHU Tivoli, La Louvière, Belgique
#Unité de Réanimation Néonatale et Pédiatrique, Rennes
**Service de Gastroentérologie, Hépatologie et Nutrition Pédiatriques, Hôpital Necker-Enfants Malades, Paris, France.
Address correspondence and reprint requests to Jacques Rigo, MD, PhD, Bât. J36 Pédiatrie-Néonatologie Boulevard du 12ème de Ligne 4000 Liège Belgique (e-mail: J.Rigo@ulg.ac.be).
Received 3 May, 2011
Accepted 16 August, 2011
J. Rigo and A. Lapillonne have received consulting fees from Baxter Healthcare. T. Senterre, J. M. Hascoet, G. Malfilâtre, and P. Pladys received fees for patient recruitment in the clinical study. E. Kermorvant-Duchemin has no financial relationships to disclose. V. Colomb has received consulting fees from Fresenius-Kabi and Baxter Healthcare. J. Rigo and V. Colomb are members of an advisory panel for the manufacturer of the Ped3CB system (Baxter Healthcare). M. Marlowe and D. Bonnot are employees of Baxter Healthcare. T. Senterre, A. Lapillonne, E. Kermorvant-Duchemin, J.M. Hascoet, G. Malfilâtre, and P. Pladys were investigators for the clinical study.