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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT05896267
Eligibility Criteria:
Inclusion Criteria:
* • Subject is a full-term newborn (37 weeks) to 18 months of age.
Exclusion Criteria:
* • Subject has underdeveloped skin.
* Subject has a skin condition and/or deformity at the planned application site, which would preclude sensor placement and measurements.
* Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors.
* Subject is not suitable for the investigation at the discretion of the Investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
37 Weeks
Maximum Age:
18 Months
Study:
NCT05896267
Study Brief:
Protocol Section:
NCT05896267