Safety During Use of Paediatric Triple Chamber Bag Formulas
|ClinicalTrials.gov Identifier: NCT01304394|
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : February 25, 2011
|Condition or disease||Intervention/treatment||Phase|
|Infant Nutrition Disorders Infant, Premature, Diseases Digestive System Disorders||Drug: Ped3CB||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||161 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||February 2008|
|Primary Completion Date :||December 2008|
|Study Completion Date :||June 2009|
|parenteral nutrition solution||
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304394
|CHU Tivoli La Louvière|
|Hôpital HFME - Groupement Hospitalier Est|
|CHU de Nancy- Hôpital d'Enfants|
|Maternité Régionale Adolphe Pinard|
|CHU de Nantes|
|Groupe Hospitalier Cochin-St Vincent de Paul|
|CHU de Poitiers|
|Hôpital Charles Nicolle|
|Hôpital de Hautepierre|
|Hôpital pédiatrique Gatien de Clocheville|
|Principal Investigator:||Jacques Rigo, MD, PhD||CHR Citadelle|