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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT03072667
Eligibility Criteria:
Inclusion Criteria:
1. Age \< 1 years; inpatient use only
2. PN dependency (unable to meet nutritional needs solely by enteral nutrition);
3. Present PNALD, as evidenced by two consecutive direct bilirubin \> 3.0 mg/dL (at interval of one week);
4. Failed standard therapies to prevent the progression of liver disease:
Avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding and the use of Ursodiol, if possible.
5. At the time the diagnosis PNALD is made, the patient is expected to continue PN at least an additional 3 weeks
Exclusion Criteria:
1. Any other cause of chronic liver disease (i.e., hepatitis B or C, cystic fibrosis, biliary atresia, or alpha 1 anti-trypsin deficiency etc.)
2. enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team);
3. Lack of informed consent;
4. Intent to transfer to another healthcare facility
5. allergy to any seafood product, egg protein, and/or previous allergy to Omegaven
6. active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis
7. impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis
8. unstable DM or hyperglycemia
9. stroke/embolism
10. collapse and shock
11. undefined coma status
12. recent MI
13. cholestasis due to any reason other than PNALD
14. active new infection at time of initiation of Omegaven
15. hemodynamic instability
16. unable to tolerate necessary laboratory monitoring
17. severe renal insufficiency
Sex:
ALL
Maximum Age:
1 Year
Study:
NCT03072667
Study Brief:
Protocol Section:
NCT03072667