Parenteral nutrition (PN) solutions are life saving in patients with surgical
gastrointestinal diseases. However, the use of PN in pediatric populations, especially
premature infants, is frequently associated with liver injury that may ultimately result in
hepatic failure. In studies conducted in a murine model, we observed that intravenous fat
emulsions (IFE) comprised of omega-3 fatty acids were able to prevent the development of
cholestasis, a common precursor of PN-associated liver disease, as well as reverse
preexisting PNALD through a combination of factors, including improved triglyceride clearance
coupled with anti-inflammatory properties. In a case series treating patients with hepatic
cholestasis, serum bilirubin levels decreased markedly after the parenteral administration of
an omega-3 fatty acid based fat emulsion (Omegaven®). Patients tolerated this therapy and no
adverse reactions attributed to its use were observed. Based on results of these previous
studies, we propose to conduct a randomized trial aiming to gain preliminary evidence of
efficacy of an omega-3 fatty acid based IFE in preventing PNALD in children with intestinal
failure
Phase:
Phase 1
Details
Lead Sponsor:
Boston Children's Hospital Boston Children’s Hospital