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Preventing Cholestasis Using SMOFLipid®

NCT01585935 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2018-01-09

No results posted yet for this study

Summary

Preterm infants of extreme low birth weight (ELBW, \< 1000 gram birth weight) cannot immediately be nourished with mother´s or formula milk and are typically dependent on parenteral nutrition (PN) for a prolonged period of time. This puts them at risk for liver complications of PN, namely parenteral nutrition associated cholestasis (PNAC).

Intravenous lipid emulsions (ILE) based on soy bean oil are standard of care for provision of energy and essential fatty acids in preterm infants. However, they might be implicated in the pathogenesis of PNAC.

ILEs based on pure fish oil are proposed for therapy of PNAC. Recently a lipid emulsion containing 15 % fish oil together with soy bean, olive and MCT oil has become available in Europe (SMOFLIPID®). Such a balanced lipid emulsion might be more favourable than the standard soy bean oil emulsion (Intralipid®) concerning the development of PNAC. Furthermore ILEs containing fish oil might exert a positive effect on neurodevelopment. However, there are no data so far.

The study aims to evaluate the fish oil containing ILE "SMOFlipid®" for its protective effect against PNAC in ELBW infants compared to standard treatment with the soy bean based ILE "Intralipid®". Furthermore neurodevelopment at 12 and 24 months of corrected gestational age will be investigated.

Conditions

  • Cholestasis
  • Psychomotor Disorders, Developmental

Interventions

DRUG

SMOFLIPID

target dose: 3g/kg/d

DRUG

INTRALIPID

target dose: 3g/kg/d

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Andreas Repa, MD · Medical University Vienna

  • Nadja Haiden, MD · Medical University Vienna

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
5 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-06-30
Completion
2017-11-13

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01585935 on ClinicalTrials.gov