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Safety During Use of Paediatric Triple Chamber Bag Formulas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01304394
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : February 25, 2011
Information provided by:
Baxter Healthcare Corporation

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.

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
parenteral nutrition solution 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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01304394

CHR Citadelle
Liege, Belgium
CHU Tivoli La Louvière
Louviere, Belgium
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, France
Sponsors and Collaborators
Baxter Healthcare Corporation
Principal Investigator: Jacques Rigo, MD, PhD CHR Citadelle

Responsible Party: Baxter Healthcare (Denis Bonnot), Baxter Healthcare Identifier: NCT01304394     History of Changes
Other Study ID Numbers: Ped3CB/P01/06/Mu.B
2007-001378-97 ( EudraCT Number )
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: February 25, 2011
Last Verified: February 2011

Keywords provided by Baxter Healthcare Corporation:
Parenteral Nutrition
Multi Chamber Bag

Additional relevant MeSH terms:
Nutrition Disorders
Infant, Premature, Diseases
Infant Nutrition Disorders
Digestive System Diseases
Gastrointestinal Diseases
Pathologic Processes
Infant, Newborn, Diseases