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SMOFlipid for Preventing Cholestasis in Premature Infants
NCT01585935Phase 4
Key facts
- Status
- Completed
- Start
- Jun 2012
- Primary completion
- Jun 2015
- Countries
- 1
- Sponsor
- Medical University of Vienna
- Modality
- Lipid-based Nanoparticles
- Drugs
- SMOFlipid
- Conditions
- parenteral nutrition-associated cholestasis (PNAC)
01
Overview
Phase 4, randomised, double-blind trial of SMOFlipid in parenteral nutrition-associated cholestasis (PNAC) (2 arms), sponsored by Medical University of Vienna. Primary endpoint: Incidence of Parenteral Nutrition Associated Cholestasis. Started Jun 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Smoflipid
SMOFlipid (mixture of soy, fish, MCT and olive oil)
Intralipid
Intralipid (soy bean oil)
03
Who it enrols
Extremely low birth weight infants (<= 1000g) admitted in the first 24 hours of life, randomized within 5 days. Excludes triplets, pre-existing cholestasis, viral infections (CMV, HIV, Hep B, Hep C), metabolic errors, cystic fibrosis, and congenital neurological malformations.
04
Endpoints
Primary
Incidence of Parenteral Nutrition Associated Cholestasis
Secondary
Bailey Scales of Infant Development III
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