Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT00826020
Eligibility Criteria:
Inclusion Criteria:
* Patients must be enrolled in the Intestinal Rehabilitation Program at the University of Nebraska Medical Center, AND:
* Be unable to meet nutritional needs solely by enteral nutrition and be expected to require PN for at least another 30 days
* Have clinical evidence of parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more. A liver biopsy is desirable but not necessary for treatment
* Signed patient informed consent
Exclusion Criteria:
* Parent or guardian or child unwilling to provide consent or assent
* Inability or unwillingness on the part of parent/guardian or child to follow clinical recommendations of the Intestinal Rehabilitation Program
* Allergies or clinical conditions precluding safe use of Omegaven™
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT00826020
Study Brief:
Protocol Section:
NCT00826020