Overview

Preventing Cholestasis Using SMOFLipid®

Status:
Completed
Trial end date:
2017-11-13
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medical University of Vienna
Treatments:
SMOFlipid
Soybean oil, phospholipid emulsion
Criteria
Inclusion Criteria:

- Birth weight ≤ 1000 Gram

- Admission to the neonatal ward in the first 24 hours of life

- Informed consent and randomization in the first 5 days of life

Exclusion Criteria:

- Triplets or higher

- Conjugated bilirubin > 1.5 mg/dl before inclusion to the study

- Conditions associated with cholestasis independent of parenteral nutrition, i.e.
inborn errors of metabolism, viral infections (cytomegaly virus, HIV, Hep B, Hep C),
immune mediated hemolytic disease (Rhesus incompatibility), cystic fibrosis and any
other primary cholestatic disease

- Congenital neurological malformations for secondary outcome