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 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT03383757
Eligibility Criteria:
Inclusion Criteria:
1. Parents or legally authorized representative (LAR) can understand and provide written informed consent; AND
2. Subjects are \< 29 days old, and requiring arterial blood samples per the site's standard of care.
Exclusion Criteria:
1. Neonates with injuries, deformities or abnormalities may prevent proper application of the sensor;
2. Neonates with inadequate heart pump function affecting blood circulation caused by identified cardiac or cardiovascular conditions such as patent ductus arteriosus, persistent pulmonary hypertension, septal defects, or congenital heart disease;
3. Neonates with mean arterial blood pressure \< 20mmHg;
4. Neonates with congenital diaphragmatic hernia; OR
5. Neonates under High frequency ventilation therapy.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
29 Days
Study:
NCT03383757
Study Brief:
Protocol Section:
NCT03383757