Safety During Use of Paediatric Triple Chamber Bag Formulas

Infant, Premature, Diseases Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304394
• Other study ID #: Ped3CB/P01/06/Mu.B
• Secondary ID: 2007-001378-97
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2011
• Last updated: February 24, 2011
• Start date: February 2008
• Est. completion date: June 2009

Study information

• Verified date: February 2011
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Hospitalized preterm newborn infants, term infants and toddlers, and children and adolescents requiring parenteral nutrition (PN) for at least 5 consecutive days.

• Preterm infants were to require PN representing, at baseline, 80% of total estimated nutritional needs, and patients in the other groups (term infants toddlers; children) were to require PN representing, at baseline, at least 50% of total estimated nutritional needs.

• Patient whose parents or legally authorized representative had provided signed written informed consent

Exclusion Criteria:

• Patients with a life expectancy < 6 days or with a severe illness with foreseeable intercurrent events that could jeopardize the patient's participation in the study were not included in the study.

• Patients with a diagnosis of shock, cardiac or renal failure with fluid overload, metabolic acidosis, respiratory failure, signs of sepsis, severe dyslipidemia, uncorrected metabolic disorders, severe sepsis, severe liver disease including cholestasis icterus, blood coagulation disorders and/or thrombophlebitis, acute myocardial infarction, or hypersensitivity to the active substance or any of the excipients of the test product, were not included in the study.

• Patients with specific nutritional requirements that could not be met by Ped3CB formulas were also excluded.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Belgium	CHR Citadelle	Liege
Belgium	CHU Tivoli La Louvière	Louviere
France	Hôpital HFME - Groupement Hospitalier Est	Bron
France	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	Hôpital Charles Nicolle	Rouen
France	Hôpital de Hautepierre	Strasbourg
France	Hôpital pédiatrique Gatien de Clocheville	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Yes
Secondary	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.	measurements were taken on day 0-5 and up to day 10 on preterms	No