Safety During Use of Paediatric Triple Chamber Bag Formulas
2 other identifiers
interventional
161
2 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2008
Shorter than P25 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 23, 2011
CompletedFirst Posted
Study publicly available on registry
February 25, 2011
CompletedFebruary 25, 2011
February 1, 2011
10 months
February 23, 2011
February 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
nutritional intakes received, change from baseline body weight
measurements were taken on day 0-5 and up to day 10 on preterms
Study Arms (1)
parenteral nutrition solution
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
CHR Citadelle
Liège, Belgium
CHU Tivoli La Louvière
Louvière, 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
Related Publications (1)
Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
PMID: 33006765DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacques Rigo, MD, PhD
CHR Citadelle
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 23, 2011
First Posted
February 25, 2011
Study Start
February 1, 2008
Primary Completion
December 1, 2008
Study Completion
June 1, 2009
Last Updated
February 25, 2011
Record last verified: 2011-02