Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children

Kapiolani Medical Center For Women & Children

Status and phase

Completed

Phase 3

Conditions

Cholestasis

Treatments

Drug: Omega-3 fish oil lipid emulsion

Study type

Interventional

Funder types

Other

Identifiers

NCT01194063

107954

Details and patient eligibility

About

Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.

Full description

Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV fat emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acids reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions. It is thought that by administering Omegaven™ in place of conventional phytosterol/soybean fat emulsions, cholestasis may be prevented or reversed, and patients will be able to be maintained on adequate PN for growth until they are able to ingest adequate nutrition enterally. Ongoing studies are addressing safety and efficacy of Omegaven™ in the pediatric population. In this trial, infants and children with parenteral nutrition associated liver disease will receive Omegaven™ as compassionate use to potentially prevent progression of disease. Safety and efficacy are monitored.

Enrollment

36 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

direct bilirubin > 2 mg/dl x2 consecutive
parenteral nutrition dependent, expected to continue for at least another 30 days from the first day
patient must have utilized standard therapies to prevent the progression of liver disease

Exclusion criteria

other primary cause of liver disease not parenteral nutrition-associated
weight <3 kg
infant or child enrolled in other clinical trial involving an investigational agent