Hepatoprotective role of SMOFlipid® used in short-term parenteral nutrition in an Onco-Hematology Pediatric Population, pilot study

Phase 1

Conditions: parenteral nutrition in an Onco-Hematology Pediatric Population
MedDRA version: 18.0Level: HLTClassification code 10065877Term: Dietary and nutritional therapiesSystem Organ Class: 100000004865
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-001614-94-FR

Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
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

Liver function tests disrupted
Patient with an infectious syndrome at the time of inclusion
Patient with a tumor or liver metastases
Patient with against-indication to the use of lipid emulsions

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: To assess the impact on hepatic function laboratory tests, tolerance to lipids, number of infectious episodes, and the impact on inflammatory proteins;Primary end point(s): dosage of ?GT in UI/l;Timepoint(s) of evaluation of this end point: D0, D5, D7

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): asat, alat, PAL, LDH, total bilirubin<br>CRP, IL-6<br>Triglycerids<br>Digestive tolerance (vomiting)<br>Infectious episodes (numbers, duration)<br>Nutritionnal status (Albumin, weight, BMI)<br>;Timepoint(s) of evaluation of this end point: D0, D5, D7