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 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT01585935
Eligibility Criteria:
Inclusion Criteria:
* Birth weight ≤ 1000 Gram
* Admission to the neonatal ward in the first 24 hours of life
* Informed consent and randomization in the first 5 days of life
Exclusion Criteria:
* Triplets or higher
* Conjugated bilirubin \> 1.5 mg/dl before inclusion to the study
* Conditions associated with cholestasis independent of parenteral nutrition, i.e. inborn errors of metabolism, viral infections (cytomegaly virus, HIV, Hep B, Hep C), immune mediated hemolytic disease (Rhesus incompatibility), cystic fibrosis and any other primary cholestatic disease
* Congenital neurological malformations for secondary outcome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
5 Days
Study:
NCT01585935
Study Brief:
Protocol Section:
NCT01585935