NCT01304394

Safety During Use of Paediatric Triple Chamber Bag Formulas

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infant Nutrition Disorders
• Infant, Premature, Diseases
• Digestive System Disorders

Interventions

Type	Name	Description
DRUG	Ped3CB	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.

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-12-01
• Completion: 2009-06-01
• First posted: 2011-02-25
• Last updated: 2011-02-25

Locations

13 sites across 2 countries: Belgium, France