Safety During Use of Paediatric Triple Chamber Bag Formulas
NCT ID: NCT01304394
Last Updated: 2011-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
161 participants
INTERVENTIONAL
2008-02-29
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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parenteral nutrition solution
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Responsible Party
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Baxter Healthcare
Principal Investigators
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Jacques Rigo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHR Citadelle
Locations
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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
Countries
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References
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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.
Other Identifiers
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2007-001378-97
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Ped3CB/P01/06/Mu.B
Identifier Type: -
Identifier Source: org_study_id