Preventing Cholestasis in Premature Infants Using SMOFLIPID
Primary endpoint: Extreme low birth weight (ELBW) infants are at high risk for development of parenteral nutrition associated cholestasis (PNAC). There is growing evidence for a positive effect of fish oil based intravenous lipid emulsions (ILE) for the treatment of PNAC. Primary use of a fish oil containing ILE for PN may prevent the development of PNAC.
Secondary endpoint: ELBW infants accumulate a deficit of omega3-LC-PUFA (especially DHA), which are important for neurodevelopment. An ILE containing fish oil provides these fatty acids and would reduce the deficit in ELBW infants, which may improve their neurocognitive development.
Primary Objective: To investigate whether ELBW infants treated with two different lLEs (investigational drug: SMOFlipid, comparative
drug: Intralipid) differ in the occurrence of PNAC (conjugated bilirubin > 1.5 mg/dl, measured on two consecutive occasions).
Secondary Objectives: To investigate whether ELBW infants treated with two different lLEs (investigational drug: SMOFlipid, comparative
drug: Intralipid) differ in their neurodevelopment (Bailey Scales of lnfant Development ll) at 12 and 24 months of corrected gestational age
Population: Extreme low birth weight (ELBW) infants
Recruitment: About 90 ELBW infants are admitted to our unit each year in the first 24 hours of life. We expect to recruit 90 % (81 patients/a year) to the study.
Losses to follow up: 63 patients are expected to be discharged from hospital each year. Based on a follow up rate of 60% after discharge in 2009 (Fuiko R, unpublished data), we expect about 38/63 patients to be available for anaylsis of the secondary outcome each year. ln the end we expect to lose 80/200 patients to follow up.
Study medication: SMOFlipid 200 mg/ml Emulsion (mixed parenteral lipid emulsion containing fish oil) for infusion, and lntralipid 20% (soybean oil based lipid emulsion) emulsion for lnfusion.
Laboratory tests: Blood counts and complete blood chemistry is routinely performed according to the local standard of care at the unit at least every 10 +/- 4 days until discharge from hospital. No additional blood sampling or analyses will be performed in study subjects in comparison to standard of care of ELBW infants.
Aims: Whether extremly low birth weight infants <1000 gram treated with two differents parenteral Lipids SMOF-LIPID (fish oil) or INTRA-LIPID (soya oil) differ in the development of cholestiasis.
Whether ELBW infants treated with SMOF- or INTRA-LIPID differ in their neurodevelopment (Bailey Scales of lnfant ll) at 12 and 24 months of corrected gestational age
Methods and Skills:
Widhalm K, Binder CB, Kreissl A, Aldover-Macasaet E , Fritsch M, Kroisböck S, Geiger H. Sudden death in a 4-year-old boy: a near-complete occlusion of the coronary artery caused by an aggressive low-density lipoprotein receptor mutation (W556R) in homozygous familial hypercholesterolemia. Journal of Pediatrics 158: 167, 2011