Pilot Study: Hepatoprotective Role of SMOFlipid® Used in Short-term Parenteral Nutrition in an Onco-Hematology Pediatric Population

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02539316

Acronym

SMOFPILOT

Enrollment

Registered

2015-09-03

Start date

2015-06-30

Completion date

2016-10-31

Last updated

2017-04-13

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

Conditions

Dietary and Nutritional Therapies

Keywords

Parenteral Nutrition

Brief summary

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.

Interventions

DRUGSmoflipid

DRUGMédialipides

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
dosage of γGT in UI/l	Baseline	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

Measure	Time frame	Description
asat, alat, PAL, LDH, total bilirubin CRP	Baseline	—
Triglycerids Digestive tolerance (vomiting)	Baseline	—
Infectious episodes (numbers, duration)	Baseline	—
Nutritionnal status	Baseline	(Albumin, weight, BMI)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026