Inflammatory Responses to Lipid Emulsions in Children Before and After Open Heart Surgery

Phase 2/3 Completed 32 enrolled University of Alberta Stollery Children's Hospital Foundation · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This study is a blinded, randomized, controlled prospective trial comparing immune response (sepsis, inflammatory response, pulmonary vasoconstriction) in 2 groups of infants less than 3-month old receiving pre and post cardiopulmonary bypass surgery. The infants will receive 1 out of the 2 following intravenous lipid preparations: Soybean Oil (n-6), or a combination of Medium Chain Triglyceride i.e. coconut oil, Long Chain Triglyceride i.e. Soybean Oil, and Fish Oil (MCT:LCT:FO). There will be 16 subjects in each group.

Timeline

Start: 2005-11
Primary completion: —
Completion: 2007-11

Publications

Larsen BM, Goonewardene LA, Joffe AR, Van Aerde JE, Field CJ, Olstad DL, Clandinin MT. Pre-treatment with an intravenous lipid emulsion containing fish oil (eicosapentaenoic and docosahexaenoic acid) decreases inflammatory markers after open-heart surgery in infants: a randomized, controlled trial. Clin Nutr. 2012 Jun;31(3):322-9. doi: 10.1016/j.clnu.2011.11.006. Epub 2011 Dec 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Coconut oil	Unknown	—	Intravenous
Subject	Fish oil	Other / unclassified	—	Intravenous
Background	Soybean Oil	Unknown	—	Intravenous

Indications

No indication recorded.