The study is not focussed on a particular pathology but rather on the use of triple chamber bags in paediatrics, in any pathology requiring parenteral nutrition MedDRA version: 9.1 Level: PT Classification code 10051284 Term: Parenteral nutrition
Conditions
Interventions
Product Name: Ped3CB 300 ml
Product Code: Ped3CB
Pharmaceutical Form: Emulsion for infusion
INN or Proposed INN: Amino acid solution (Amino acid blend P
Sponsors
Baxter SAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients of both genders, with no prespecified gender distribution, - With the following age distribution: * preterm newborn infants (up to 36 weeks gestation) (ICH E11 age group 1) for bag 300 ml, or * term newborn infants to toddlers (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patient whose parents are minors, - Participation in another investigational drug study in the 4 weeks before inclusion, - Patient previously included in this study, - Patient with life expectancy shorter than 6 days, - Severe illness with foreseeable intercurrent events jeopardizing patient’s participation by leading to drop out, - Known HIV, known pregnancy in adolescent, - Known congenital abnormalities of amino acid metabolism, - Shock, cardiac or renal failure with fluid overload (hyperhydration), metabolic acidosis, respiratory failure, - severe dyslipidemia and non-corrected metabolism disorders including lactic acidosis and uncompensated diabetes, - severe sepsis, - severe liver disease, - blood coagulation disorders, thrombophlebitis, - myocardial infarction, - Hypersensitivity to the active substances or any of the excipients (e.g.: egg or soybean proteins)in the Ped3CB. - specific nutritional requirements that cannot be met by Ped3CB formulas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the performance safety of the Ped3CB in paediatric patients. ;Secondary Objective: To collect information on handling and administration of the Ped3CB; Primary end point(s): Criteria for safety performance: Vital signs and adverse events will be recorded daily for the 5 days of the study in all patients and during the optional treatment period in preterm newborn infants. In the preterm newborn infants group, plasma ionogram (Na, K, Ca, P), glucose, urea, triglycerides and blood pH will be evaluated at D 0, D 5 and D 10/D end. Criteria for efficacy performance: - Handling and ease of use: Practical handling and ease of activation of the Ped3CB will be evaluated every day, at each nutrition set up through questionnaires and visual analog scales to be filled in by the nurses or the pharmacists that will activate the bag. - Body weight evolution: Body weight will be recorded before the first infusion, and after the 3rd and 5th day of infusion, and for preterm newborn infants after the last infusion in the optional tretment period. In order to evaluate patient exposure and compliance, nutritional intakes will be recorded every day over all treatment periods. | — |
Countries
Belgium, France
Outcome results
None listed