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:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2025-12-24 @ 1:16 PM
NCT ID:
NCT00793195
Eligibility Criteria:
Inclusion Criteria:
1. ≤ 24 months of age at enrollment
2. Evidence of early hepatic dysfunction
* Serum conjugated bilirubin ≥ 17 umol/L on 2 consecutive readings 7 days apart
* No evidence of sepsis
* Normal Temperature (T between 35.5C and 38.0C)
* Normal leukocyte count
* Normal platelet count
* No systemic septic symptoms
* No prior administration of Omegaven
3. ≥ 40% of total calories administered by PN
4. Meet one of the following diagnostic categories
* Short Bowel Syndrome
* Abdominal surgical procedure including gastroschisis closure by any means and percutaneous drainage procedures within the past 6 months and has been receiving PN since surgery
* Intestinal Failure
* One of the following diagnoses for which the child is dependent on PN
* Gastrointestinal Motility Disorder
* Mucosal Enteropathy
5. Expectation of the treating physician that the patient will require PN for at least 3 weeks following enrollment.
6. Parents willing to participate including randomization
Exclusion Criteria:
1. Sepsis or Hemodynamic Instability of any cause.
2. Coagulopathy (Platelets ≤ 150 000, or INR ≥ 1.4)
3. Hypersensitivity to fish-, egg- or soy protein or to any of the active substances or excipients
4. Current enrollment in another clinical trial involving a surgical or pharmacologic intervention
5. Serum conjugated bilirubin \> 50 umol/L
6. Hyperlipidaemia (any of)
* LDL ≥ 4 mmol/L
* HDL ≥ 2 mmol/L
* Total cholesterol ≥ 5 mmol/L
* Triglycerides ≥ 1.5 mmol/L
7. Treatment with intravenous N-Acetylcysteine or Ursodeoxycholic acid
8. Renal insufficiency
* Creatinine ≥ 80 umol/L
9. Disorders of Fluid Balance (any of)
* Serum Sodium \< 130 mmol/L
* Serum Sodium \> 145 mmol/L
10. Unstable conditions
* Acute pulmonary edema
* Decompensated cardiac insufficiency
* Severe post-traumatic conditions
* Uncompensated diabetes mellitus
* Acute myocardial infarction
* Stroke within 3 months
* Thromboembolic event within 3 months
* Metabolic acidosis
* Serum Bicarbonate \< 17 mmol/L
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
24 Months
Study:
NCT00793195
Study Brief:
Protocol Section:
NCT00793195