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 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT02476994
Eligibility Criteria:
Inclusion Criteria:
1. Patients and/or their legal representative must be able to understand the study and voluntarily sign the ICF
2. Patients age \<18 years
3. Patients who are able to adhere to protocol requirements
4. Patients who are expected to require PN for at least 7 days
5. Premature infants (\<36 weeks of gestation) require at least 80% PN to meet nutrition requirements at study entry; full term infants and children require at least 70% PN to meet nutrition requirements at study entry
Exclusion Criteria:
1. Patients who are not expected to survive hospitalization or with a severe illness with foreseeable intercurrent events that could jeopardize the patient's participation in the study
2. Patients with a known hypersensitivity to lipid emulsion, egg or soybean proteins, or any of the active substances, excipients, or components of the container
3. Patients with a diagnosis of shock, renal failure requiring dialysis, or severe metabolic acidosis (eg, pH \<7.10, serum bicarbonate level ≤15 mEq/L , and/or an Anion Gap \>16 mEq/L)
4. Patients with hemodynamic instability as judged by the Investigator
5. Patients with uncorrected metabolic disorders (eg, diabetes) or liver disease including cholestasis
6. Patients with severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (triglyceride \>400 mg/dL)
7. Patients who are unable to tolerate the necessary laboratory monitoring
8. Patients who have a new and active infection (as assessed by the investigator) at time of initiation of study treatment
9. Patients who are enrolled in another clinical trial involving an investigational agent
10. Patients who were treated with IV lipids within 48 hours of randomization into the study
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT02476994
Study Brief:
Protocol Section:
NCT02476994