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 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT02780193
Eligibility Criteria:
Inclusion Criteria:
Patients from birth to 18 years of age who:
* are receiving PN,
* are predicted to receive at least another 30 days of PN, and
* have liver disease with at least a serum direct (conjugated) bilirubin ≥ 2 mg/dL
* Patients from birth to 18 years of age who have a soybean allergy (per parental report) and require parenteral fat
* Patients with significant liver disease due to parenteral nutrition despite utilization of all appropriate conventional therapies.
* Signed patient/parent informed consent
* Hospitalized due to medical or surgical condition prior to Omegaven initiation
Exclusion Criteria:
* Those who do not fulfill the inclusion criteria
* Those who choose not to consent to the study
* Those in whom 3rd party funding is not secured to support this investigational treatment
* Known fish or egg protein allergy (per parental report)
* All other causes of liver disease (cystic fibrosis, biliary atresia, and alpha 1 anti- trypsin deficiency)
* Severe hemorrhagic disorders (platelet count below 50000)
* Collapse and shock
* Embolism
* Undefined coma status
* Impaired lipid metabolism (serum triglycerides \> 200 mg/dL on 1 g/kg/day intralipid)
* Unstable diabetes mellitus
* Stroke
* Recent cardiac infarction
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT02780193
Study Brief:
Protocol Section:
NCT02780193