Dietary and Nutritional Therapies Clinical Trial
— SMOFPILOTOfficial title:
Pilot Study: Hepatoprotective Role of SMOFlipid® Used in Short-term Parenteral Nutrition in an Onco-Hematology Pediatric Population
| Verified date | April 2017 |
| Source | Centre Hospitalier Universitaire de Nice |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 9 |
| Est. completion date | October 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 18 Years |
| Eligibility |
Inclusion Criteria: - 0-18 years - Solid Tumors - hematological malignancies - Requiring parenteral nutrition during at least 5 days - With a central catheter - With a normal hepatic function test Exclusion Criteria: - Liver function tests disrupted - Patient with a tumor or liver metastases - Patient with against-indication to the use of lipid |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital de l'Archet - CHU de Nice | Nice |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nice |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | dosage of ?GT 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. | Baseline | |
| Primary | dosage of ?GT in UI/l | at day 5 | ||
| Primary | dosage of ?GT in UI/l | 7 days after the end of parenteral nutrition | ||
| Secondary | asat, alat, PAL, LDH, total bilirubin CRP | Baseline | ||
| Secondary | asat, alat, PAL, LDH, total bilirubin CRP | at day 5 | ||
| Secondary | asat, alat, PAL, LDH, total bilirubin CRP | 7 days after the end of parenteral nutrition | ||
| Secondary | Triglycerids Digestive tolerance (vomiting) | Baseline | ||
| Secondary | Triglycerids Digestive tolerance (vomiting) | at day 5 | ||
| Secondary | Triglycerids Digestive tolerance (vomiting) | 7 days after the end of parenteral nutrition | ||
| Secondary | Infectious episodes (numbers, duration) | Baseline | ||
| Secondary | Infectious episodes (numbers, duration) | at day 5 | ||
| Secondary | Infectious episodes (numbers, duration) | 7 days after the end of parenteral nutrition | ||
| Secondary | Nutritionnal status | (Albumin, weight, BMI) | Baseline | |
| Secondary | Nutritionnal status | (Albumin, weight, BMI) | at day 5 | |
| Secondary | Nutritionnal status | (Albumin, weight, BMI) | 7 days after the end of parenteral nutrition |