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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001614-94-FR

Enrollment

Unknown

Registered

2015-07-24

Start date

2015-07-03

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

parenteral nutrition in an Onco-Hematology Pediatric Population MedDRA version: 18.0 Level: HLT Classification code 10065877 Term: Dietary and nutritional therapies System Organ Class: 100000004865

Interventions

Trade Name: SMOFLIPID Pharmaceutical Form: Emulsion for infusion Trade Name: MEDIALIPIDE Pharmaceutical Form: Emulsion for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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

Countries

France

Contacts

Public ContactLANDES

Centre Hospitalier Universitaire de Nice

landes.c@chu-nice.fr+33492034126

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026