This trial is completed!
Search for a recruiting clinical trial for your condition
Your journey
1What's a trial
2Find
3Review
4Get in touch
More info
You can access this
clinical trial
if you have
Cholestasis or Psychomotor Disorders, Developmental
and you are
under 5
years old
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
Show me locations

The purpose

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.

Provided treatments

  • Drug: SMOFLIPID
  • Drug: INTRALIPID

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01585935. The sponsor of the trial is Medical University of Vienna and it is looking for 230 volunteers for the current phase.
Official trial title:
Preventing Cholestasis in Premature Infants Using SMOFLipid®