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 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT03482505
Eligibility Criteria:
Inclusion Criteria:
* Subjects weighing up to 10kg
* Subjects will be inpatients and/or outpatients admitted to the NICU (Neonatal Intensive Care Unit) or PICU (Pediatric Intensive Care Unit) or PACU (Post-Anaesthesia Care Unit)
* The parent/legal guardian has given written informed consent/assent to participate in the study.
Exclusion Criteria:
* Subjects with underdeveloped skin
* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, infections, abnormalities, etc.
* Subjects deemed not suitable for the study at the discretion of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03482505
Study Brief:
Protocol Section:
NCT03482505