No special medical condition but Patient requiring for any underlying pathology at least 5 days of total parenteral nutrition, representing at least 90% of their total energy needs
Conditions
Interventions
Trade Name: INFUVITE PEDIATRIC
Product Name: Clinavit Pediatric
Pharmaceutical Form: Intravenous infusion
Other descriptive name: Infuvite
Concentration unit: % percent
Concentration type: range
Conce
Sponsors
BAXTER SAS R&D Parenteral Nutrition
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·In or out patients of both genders,· Aged up to 11 years of age at the first visit,· Patient requiring for any underlying pathology at least 5 days of total parenteral nutrition, representing at least 90% of their total energy needs,· Patient to be supplemented by intravenous vitamins,· Patient whose parents or legal representative have freely given their written informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ·Known HIV infection,· Known pre-existing hypervitaminosis,· Known hypersensitivity to intravenous vitamins, or any excipients of the preparation,· Participation in another clinical trial within a month prior to the first visit, · Patient with any underlying pathology at risk of foreseeable drop out before the 6th day,· Patients requiring treatment by anticonvulsants (barbiturics or phenytoin),· Patients requiring an extra supplementation by products containing vitamins, whatever the route,· Previous inclusion in this study,· Parents or legal representative’s potential non-cooperation or unwillingness to comply fully with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Main Objective: Main objective : To confirm that Clinavit Paediatric is an efficient and safe alternative to Soluvit and Vitalipid Infant, the current vitamins cocktail used for parenteral nutrition supplementation in neonates, infants and children up to 11 years of age, through the assessment of:· The blood levels of the most commonly explored vitamins in literature as surrogate markers of effective intake,· The vital signs and adverse events occurring within the 5-day treatment period.;Primary end point(s): Efficiency criteria:Plasma level of 2 oil-soluble vitamins (A and E) and 2 water-soluble ones (folates and B12) as surrogate markers of effective intake. Blood levels of retinol binding protein and lipids (total cholesterol and triglycerides) as carriers of vitamin A and E respectively and total proteins, as carrier for other vitamins, will be examined in case of abnormal vitamins blood level values. Safety criteria: Vital signs and adverse events | — |
Countries
Spain
Outcome results
None listed