Digestive System Disorders, Infant Nutrition Disorders, Infant, Premature, Diseases
Conditions
Keywords
Parenteral Nutrition, Multi Chamber Bag
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.
Interventions
DRUGPed3CB
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.
Sponsors
Baxter Healthcare Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Practical handling,ease of use and safety information (number of participants with adverse events) | 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
| Measure | Time frame | Description |
|---|---|---|
| nutritional intakes received, change from baseline body weight | 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. |
Countries
Belgium, France
Outcome results
None listed