The primary objective of this study was to provide daily information on the performance safety of the Ped3CB in practical therapeutic use in pediatric patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
161
The Ped3CB is a ready to use, triple-chamber bag containing a sterile, nonpyrogenic combination of amino acids (Primene®, Baxter) with electrolytes, glucose, and lipids (ClinOleic®, Baxter) in separate compartments for intravenous (IV) PN. The dosage, frequency and duration is dependent on patient's weight, age, clinical status as well as addition energy or protein given enterally/orally.
CHR Citadelle
Liège, Belgium
CHU Tivoli La Louvière
Louvière, Belgium
Hôpital HFME - Groupement Hospitalier Est
Bron, France
Practical handling,ease of use and safety information (number of participants with adverse events)
Practical handling and ease of use were measured with questionnaires and a VAS assessment of the Ped3CB, which was to be compared with the standard practice of the pharmacy or nursing ward at each site. All AEs were recorded during study treatment through 2 days after the last infusion. Vital signs and adverse events were recorded daily for the 5 days of the study in all patients and during the optional treatment period (an additional 5 days) in preterm newborn infants.
Time frame: measurements were taken on day 0-5 and up to day 10 on preterms and through 2 days after the last infusion of study product
nutritional intakes received, change from baseline body weight
Nutritional intakes, particularly the Ped3CB dose, were recorded daily during the treatment period. Body weight was measured and recorded daily. Changes from baseline to end of treatment were evaluated.
Time frame: measurements were taken on day 0-5 and up to day 10 on preterms
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CHU de Nancy- Hôpital d'Enfants
Nancy, France
Maternité Régionale Adolphe Pinard
Nancy, France
CHU de Nantes
Nantes, France
Groupe Hospitalier Cochin-St Vincent de Paul
Paris, France
Hôpital Necker
Paris, France
CHU de Poitiers
Poitiers, France
Hôpital Pontchaillou
Rennes, France
...and 3 more locations