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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT01050660
Eligibility Criteria:
Inclusion Criteria:
* Preterm infants less than or equal to 29 weeks' gestation
* Age less than 48 hours
Exclusion Criteria:
* Congenital intrauterine infection, known to be associated with liver involvement and cholestasis
* Known structural liver abnormalities that are associated with cholestasis
* Known genetic disorders: trisomy 21, trisomy 13 and trisomy 18
* Inborn errors of metabolism
* Infants meeting the criteria for terminal illness (eg, pH \< 6.8 \> 2 hours)
* Inability to obtain informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Hours
Maximum Age:
48 Hours
Study:
NCT01050660
Study Brief:
Protocol Section:
NCT01050660