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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT04894669
Eligibility Criteria:
Inclusion Criteria:
* Less than or equal to 1 month of age
* Gestational age greater than 23 weeks
* Weight less than or equal to 5 kg
* Subjects with standard of care arterial blood sampling line already in place
Exclusion Criteria:
* Subjects with underdeveloped skin
* Subjects with abnormalities at the planned application sites that would interfere with system measurements
* Subjects with known allergic reactions to foam/rubber products and adhesive tape
* Subjects with axillary arterial lines
* Deformities of the limbs, absence of the feet, severe edema, and other at the discretion of the Principal Investigator
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
1 Month
Study:
NCT04894669
Study Brief:
Protocol Section:
NCT04894669