Safety During Use of Paediatric Triple Chamber Bag Formulas

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Infant Nutrition Disorders, Infant, Premature, Diseases, Digestive System Disorders

Intervention / Treatment
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* Drug: Ped3CB


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: parenteral nutrition solution<br> | Drug: Ped3CB<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parenteral Nutrition, Multi Chamber Bag