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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT02971566
Eligibility Criteria:
Inclusion Criteria:
* gestational age ≤34 weeks
* stable clinical conditions
* documented evidence of antenatal umbilical Doppler impairment
* written informed consent obtained from parents/guardians
Exclusion Criteria:
* Enteral feeding prior to the enrollment
* Major congenital abnormalities (including congenital heart diseases, gastroschisis, exomphalos)
* Hemodynamic instability, hypotension, patent ductus arteriosus, anemia, sepsis or other infections at time of NIRS monitoring
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
2 Months
Study:
NCT02971566
Study Brief:
Protocol Section:
NCT02971566