Clinical Trial: Preventing Cholestasis Using SMOFLipid®
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Preventing Cholestasis in Premature Infants Using SMOFLipid®
Brief 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.
Detailed Summary:
BACKGROUND: Extreme low birth weight infants (ELBW, < 1000 gram birth weight) are typically dependent on parenteral nutrition (PN) for a prolonged period of time. This puts them at risk for development of liver complications of PN, namely parenteral nutrition associated cholestasis (PNAC).
Intravenous lipid emulsion (ILE) based on soy bean oil are standard of care in preterm infants, but might be implicated in the pathogenesis of PNAC. Fish oil is rich in omega-3 long chain polyunsaturated fatty acids (LC-PUFA) that particularly accumulate in liver and brain of the fetus during the last trimester of pregnancy. In pediatric patients, ILEs based on pure fish oil are proposed as a rescue therapy of PNAC.
Recently a mixed lipid emulsion containing 15 % fish oil together with soy bean , olive and MCT oil has become available for PN in Europe. 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.
AIM: To evaluate a fish oil containing ILE (SMOFlipid®) for its prophylactic effect on PNAC in ELBW infants compared to a soy bean based ILE (Intralipid®).
STUDY DESIGN: Double blind prospective randomized trial.
- Primary Outcome: PNAC defined as two conjugated bilirubin > 1.5 mg/dl measurements on two consecutive occasions.
- Secondary Outcome: The most important secondary outcome is neurodevelopment at 12 and 24 months of corrected age.
- Exploratory Outcomes: B
Sponsor: Medical University of Vienna
Current Primary Outcome: Incidence of parenteral nutrition associated cholestasis (PNAC) [ Time Frame: Participants will be followed for the duration of hospital stay (expected average 14 weeks) ]
PNAC definition: Two consecutive conjugated bilirubin measurements > 1.5 mg/dl
Original Primary Outcome: Same as current
Current Secondary Outcome: Bailey Scales of Infant Development III [ Time Frame: At 12 and 24 months corrected gestational age ]
Cognitive, Motor and Language Development
Original Secondary Outcome: Bailey Scales of Infant Development II [ Time Frame: At 12 and 24 months corrected gestational age ]
Psychomotor (PDI) and mental (MDI) developmental index
Information By: Medical University of Vienna
Dates:
Date Received: April 16, 2012
Date Started: June 2012
Date Completion: December 2017
Last Updated: February 8, 2017
Last Verified: February 2017
