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 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
NCT ID:
NCT06817850
Eligibility Criteria:
Inclusion Criteria:
* Observations of any infant in the neonatal ICU with two simultaneous oximeter monitors may be included. The sites' Ethics Committee must review the protocol, approve participation and determine if Informed Consent is required. If required, it might be prospective, that is prior to collecting any data, or retrospective.
Exclusion Criteria:
* Observations are to be made at the convenience of the Investigative team. They should reflect routine situation, and not be selected to specifically capture problems. Thus, the photo should be taken immediately with both displays are on in the view, and not delayed until something interesting happens. Observations should not be made if any of the following exclusion criteria are meet. If after collection, any of these are meet, the data should not be included as an Observation on the Observation-CRF.
* One oximeter monitoring post ductal SpO2 in infant with clinically relevant shunt.
* Monitor and A-FiO2 Oximeter not reading between 70-100%
* Less than 5 minutes between repeat Observations
* No more than 5 measurements per day per subject with sensors in same position and same oximeters (i.e., every time either sensor is moved, 5 new Observations can be made that day).
* Presence of motion artifact
* Presence of sensor integrity alarms/alerts
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06817850
Study Brief:
Protocol Section:
NCT06817850