Safety During Use of Paediatric Triple Chamber Bag Formulas

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01304394
First received: February 23, 2011
Last updated: February 24, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Infant Nutrition Disorders
Infant, Premature, Diseases
Digestive System Disorders
Drug: Ped3CB
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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:
  • nutritional intakes received, change from baseline body weight [ Time Frame: measurements were taken on day 0-5 and up to day 10 on preterms ] [ Designated as safety issue: No ]

    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.



Enrollment: 161
Study Start Date: February 2008
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Ped3CB

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304394

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

No publications provided

Responsible Party: Baxter Healthcare (Denis Bonnot), Baxter Healthcare
ClinicalTrials.gov Identifier: NCT01304394     History of Changes
Other Study ID Numbers: Ped3CB/P01/06/Mu.B, 2007-001378-97
Study First Received: February 23, 2011
Last Updated: February 24, 2011
Health Authority: European Union: European Medicines Agency

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

Additional relevant MeSH terms:
Disease
Nutrition Disorders
Malnutrition
Infant, Premature, Diseases
Infant Nutrition Disorders
Digestive System Diseases
Gastrointestinal Diseases
Pathologic Processes
Infant, Newborn, Diseases
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014