Blood samples will be drawn before initiation of lipids at either DOL-0 or DOL-1, and then at DOL-4 and DOL-7. Serum triglycerides is the primary outcome indicator of tolerance to the initiation and advancement of lipid injectable emulsion. The dosing protocol for all neonates is weight- and age-based, as shown below:ĭOL1- 0 DOL2- 1 DO元- 2 DOL4- 3 DOL5- 3 DOL6+-3 The study is a single-center (BIDMC), prospective, single-blinded, randomized controlled study involving neonatal ICU patients who will receive lipid injectable emulsion infusions as part of their normal clinical care. Condition or diseaseĭrug: Liposyn III 20% (lipid infusion) Drug: Intralipid 20% (lipid infusion) The study will attempt to discern whether the differences in packaging influence the stability and subsequent tolerance of lipid injectable emulsions. We will compare the incidence of hypertriglyceridemia in neonates between lipids packaged in glass versus those in plastic. We hypothesize this difference may explain the recent clinical observations. (At the present time, the USP monograph is not officially recognized, but is on track for adoption in 2006.) Our preliminary analyses of four lots of 20% lipid injectable emulsion packaged in glass to have a PFAT5 of 0.003☐.0008%, compared to an approximate 55-fold increase in the large-diameter fat globule population or 0.166☐.016% for an equal number of products packaged in plastic. The United States Pharmacopeia (USP) which sets the standards for drug purity and safety in the U.S., and whose drug monographs are enforceable by the FDA, has proposed to limit this large diameter fat globule population to a volume-weighted percent fat greater than five micrometers or PFAT5 to be less than 0.05% of the total lipid concentration. Upon further laboratory investigation of the lipid injectable emulsions stored in glass bottles versus those in plastic, significant differences were noted in the population of large-diameter fat globules by globule size analysis, reflective of a less stable emulsion in plastic. In January, 2005, NICU personnel observed what appeared to be a higher than usual incidence of hypertriglyceridemia. Traditionally, lipid injectable emulsions have been commercially available in sterile glass bottles, but in April of 2004, a new container was introduced as a sterile plastic bag. Lipid injectable emulsions are an essential nutrient for neonatal growth and development. This will be a prospective, randomized trial to determine if differences exist in the tolerance of lipid injectable emulsions in the neonatal intensive care unit (NICU). Why Should I Register and Submit Results?.Fat Emulsion also provides calories in the form of glycerin and fatty acids. Fat Emulsion lipid component supplies essential fatty acids and contributes to essential fatty acid requirements. Fat Emulsion is intended for the treatment of adult and pediatric patients with parenteral nutrition support who are unable to ingest adequate amounts of nutrients orally or by other parenteral routes. Fat Emulsion is administered by intravenous injection. Fat Emulsion is a milk-based emulsion containing 20% Intralipid, 2.5% glycerin, and 0.45% sodium caprylate, with water for injection. Fat Emulsion is a sterile, nonpyrogenic, white to slightly yellow lipid emulsion. The emulsion droplets have an average diameter of about 200 nanometers. The lipid components are composed of 97% soybean oil, 2% egg yolk phospholipids, and 1% glycerin. It contains 20% Intralipid, 0.9% sodium chloride, and 0.45% dextrose in water for injection. Fat Emulsion is a sterile, nonpyrogenic, lipid-based emulsion for intravenous administration.
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