Clinical Trial: Safety During Use of Paediatric Triple Chamber Bag Formulas
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety During Use of Paediatric Triple Chamber Bag Formulas, Administered IV at a Weight Dependant Dose During 5 Consecutive Days, in Paediatric Patients up to 18 Years Requiring Parenteral Nutrition.
Brief Summary: 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.
Detailed Summary:
Sponsor: Baxter Healthcare Corporation
Current Primary Outcome: Practical handling,ease of use and safety information (number of participants with adverse events) [ 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 ]
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.
Original Primary Outcome: Same as current
Current Secondary Outcome: nutritional intakes received, change from baseline body weight [ Time Frame: measurements were taken on day 0-5 and up to day 10 on preterms ]
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.
Original Secondary Outcome: Same as current
Information By: Baxter Healthcare Corporation
Dates:
Date Received: February 23, 2011
Date Started: February 2008
Date Completion:
Last Updated: February 24, 2011
Last Verified: February 2011
