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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT05250102
Eligibility Criteria:
Inclusion Criteria:
* Subjects who are postnatal 28 days or younger (neonates)
* Subjects who are likely to receive one or more ABG measurements as part of their clinical SOC
* Subjects who weigh less than 5 Kg (weight range for thesensors)
Exclusion Criteria:
* Subjects with current signs and symptoms of a clinically significant Patent Ductus Arteriosus (PDA) combined with a current or planned arterial line placement which will affect the validity of the co-oximetry measurement
* Subjects with physical malformation of hands, fingers, feet, or toes that would limit the ability to place sensors for this study
* Subjects judged by the Principal Investigator (PI) to be inappropriate for participation in this study
* Subjects for whom placing a pulse oximeter will cause dermatological issues (e.g. allergic to foam rubber or adhesive tape)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
28 Days
Study:
NCT05250102
Study Brief:
Protocol Section:
NCT05250102