Research

Omegaven® for Infants with Gastrointestinal Diseases

Efficacy of an Omega-3 Enriched Intravenous Fat Emulsion in the Prevention of Parenteral Nutrition Induced Liver Injury in Infants

Protocol Description

The purpose of this multicenter study is to determine if infants suffering from intestinal failure and requiring parenteral nutrition (PN) will be less likely to develop liver disease if they receive Omegaven®, an experimental fat emulsion made of omega-3 fish oils, rather than Intralipid®, the standard fat emulsion which is made from soybean oils. PN is a nutritional solution given intravenously to infants who are unable to tolerate adequate oral feedings. Although PN solutions are necessary and life-sustaining, their use can sometimes result in liver disease.

Eligibility Criteria

Subject to certain screening criteria, the study will enroll infants of both genders up to 3 months of age, who are unable to digest food and absorb nutrients normally and thus require PN.
Boys: Up to 3 months
Girls: Up to 3 months

Requirements
Study participants will be randomly placed into either a group that receives PN therapy with the experimental fat emulsion Omegaven® or into a group that receives PN therapy with the standard fat emulsion Intralipid®. Patients will be monitored closely by Children’s Intestinal Care and Rehabilitation service (ICARE) for clinical signs of PN-associated liver disease.
Visits: Requires hospitalization
Duration: 6 months

Status: Open for Enrollment

Additional Resources
Study description at National Institutes of Health