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

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Completed

CT.gov ID

NCT02539316

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dietary and Nutritional Therapies	Drug: Smoflipid Drug: Médialipides	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Médialipides parenteral nutrition by Médialipides (dosage form depending child's weight as recommended by the SPC)	Drug: Médialipides
Experimental: SmofLIPID parenteral nutrition by Smoflipid (dosage form depending child's weight as recommended by the SPC)	Drug: Smoflipid

Arm

Intervention/Treatment

Active Comparator: Médialipides

parenteral nutrition by Médialipides (dosage form depending child's weight as recommended by the SPC)

Drug: Médialipides

Experimental: SmofLIPID

parenteral nutrition by Smoflipid (dosage form depending child's weight as recommended by the SPC)

Drug: Smoflipid

Outcome Measures

Primary Outcome Measures

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.
dosage of γGT in UI/l [at day 5]
dosage of γGT in UI/l [7 days after the end of parenteral nutrition]

Secondary Outcome Measures

asat, alat, PAL, LDH, total bilirubin CRP [Baseline]
asat, alat, PAL, LDH, total bilirubin CRP [at day 5]
asat, alat, PAL, LDH, total bilirubin CRP [7 days after the end of parenteral nutrition]
Triglycerids Digestive tolerance (vomiting) [Baseline]
Triglycerids Digestive tolerance (vomiting) [at day 5]
Triglycerids Digestive tolerance (vomiting) [7 days after the end of parenteral nutrition]
Infectious episodes (numbers, duration) [Baseline]
Infectious episodes (numbers, duration) [at day 5]
Infectious episodes (numbers, duration) [7 days after the end of parenteral nutrition]
Nutritionnal status [Baseline]
(Albumin, weight, BMI)
Nutritionnal status [at day 5]
(Albumin, weight, BMI)
Nutritionnal status [7 days after the end of parenteral nutrition]
(Albumin, weight, BMI)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital de l'Archet - CHU de Nice	Nice		France	06202

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT02539316

Other Study ID Numbers:

15-PP-03

First Posted:

Sep 3, 2015

Last Update Posted:

Apr 13, 2017

Last Verified:

Apr 1, 2017

Keywords provided by Centre Hospitalier Universitaire de Nice

Parenteral Nutrition

Additional relevant MeSH terms:

SMOFlipid

Study Results

No Results Posted as of Apr 13, 2017