A Phase 4 interventional study of Smoflipid and Médialipides in Dietary and Nutritional Therapies, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2017-04-13.
Sponsored by Centre Hospitalier Universitaire de Nice · Phase 4, Interventional, and Supportive care
Parenteral nutrition (PN) is part of supportive care in oncology Pediatric when the patient's nutritional status justifies it and enteral is impossible. In the literature, hepatotoxicity, cholestasis type, standard emulsions of soy oil-based (type Médialipide®) is described in the context of a long-term PN especially in premature infants. It results in an increase in gammaGT. The most recent use of lipid emulsions containing Omega 3 (Smoflipid), was studied in the adult population and in the preterm in the PN on short and long, with the finding of a hepatoprotection. Investigators do not find a single retrospective study about it in Pediatric Onco-Hematology. No prospective studies have been performed in the population of Onco-Hematology. The objective of this study is to evaluate the impact of the use of SMOFlipid® in parenteral nutrition on early occurrence of cholestasis compared with Médialipides in a short-term use of parenteral nutrition in an Onco-Hematology pediatric population.
Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
parenteral nutrition by Médialipides (dosage form depending child's weight as recommended by the SPC)
Drug: Médialipides
parenteral nutrition by Smoflipid (dosage form depending child's weight as recommended by the SPC)
Drug: Smoflipid
dosage of γGT in UI/l
to evaluate the impact of the use of SMOFlipid® in parenteral nutrition on early occurrence of cholestasis compared with Médialipides in a short-term use of parenteral nutrition in an Onco-Hematology pediatric population.
Time frame: Baseline
dosage of γGT in UI/l
Time frame: at day 5
dosage of γGT in UI/l
Time frame: 7 days after the end of parenteral nutrition
asat, alat, PAL, LDH, total bilirubin CRP
Time frame: Baseline
asat, alat, PAL, LDH, total bilirubin CRP
Time frame: at day 5
asat, alat, PAL, LDH, total bilirubin CRP
Time frame: 7 days after the end of parenteral nutrition
Triglycerids Digestive tolerance (vomiting)
Time frame: Baseline
Triglycerids Digestive tolerance (vomiting)
Time frame: at day 5
Triglycerids Digestive tolerance (vomiting)
Time frame: 7 days after the end of parenteral nutrition
Infectious episodes (numbers, duration)
Time frame: Baseline
Infectious episodes (numbers, duration)
Time frame: at day 5
Infectious episodes (numbers, duration)
Time frame: 7 days after the end of parenteral nutrition
Nutritionnal status
(Albumin, weight, BMI)
Time frame: Baseline
Nutritionnal status
(Albumin, weight, BMI)
Time frame: at day 5
Nutritionnal status
(Albumin, weight, BMI)
Time frame: 7 days after the end of parenteral nutrition
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice