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Completed

NCT Number: NCT02539316

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

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital de l'Archet - CHU de Nice

Nice, 06202, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMOFlipid

Drug

Médialipides

Drug

Primary outcomes

  1. dosage of γGT in UI/l

    Time frame: 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.

  2. dosage of γGT in UI/l

    Time frame: at day 5

  3. dosage of γGT in UI/l

    Time frame: 7 days after the end of parenteral nutrition

Secondary outcomes

  1. asat, alat, PAL, LDH, total bilirubin CRP

    Time frame: Baseline

  2. asat, alat, PAL, LDH, total bilirubin CRP

    Time frame: at day 5

  3. asat, alat, PAL, LDH, total bilirubin CRP

    Time frame: 7 days after the end of parenteral nutrition

  4. Triglycerids Digestive tolerance (vomiting)

    Time frame: Baseline

  5. Triglycerids Digestive tolerance (vomiting)

    Time frame: at day 5

  6. Triglycerids Digestive tolerance (vomiting)

    Time frame: 7 days after the end of parenteral nutrition

  7. Infectious episodes (numbers, duration)

    Time frame: Baseline

  8. Infectious episodes (numbers, duration)

    Time frame: at day 5

  9. Infectious episodes (numbers, duration)

    Time frame: 7 days after the end of parenteral nutrition

  10. Nutritionnal status

    Time frame: Baseline

    (Albumin, weight, BMI)

  11. Nutritionnal status

    Time frame: at day 5

    (Albumin, weight, BMI)

  12. Nutritionnal status

    Time frame: 7 days after the end of parenteral nutrition

    (Albumin, weight, BMI)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: SMOFPILOT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 3, 2015
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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