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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT01297933
Eligibility Criteria:
Inclusion Criteria:
* PN dependence due to congenital or acquired gastrointestinal disease
* Predicted PN requirement for at least an additional 30 days
* Parenteral nutrition associated liver disease (PNALD), defined as two conjugated bilirubin levels \>= 2 mg/dL at least one week apart, must be obtained to demonstrate persistence of PNALD
* Failure to respond to standard therapies which may include cycling PN, reduction in the dose of soybean derived IFE, attempts to advance enteral feeds, ursodiol, metronidazole, and avoidance of excessive caloric provision
* signed parent or legal guardian informed consent
Exclusion Criteria:
* Acute treatable infection (e.g. urinary tract infection, sepsis)
* Known allergy to egg or fish protein
* Contraindications to Omegaven
* Pregnancy
* Serum triglyceride level greater than 400 mg/dL at baseline
* History of severe hemolytic disorders or INR greater than 1.5 at baseline (INR cutoff of greater than 2 for infants less than 1 week of age)
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT01297933
Study Brief:
Protocol Section:
NCT01297933