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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT03549520
Eligibility Criteria:
Inclusion Criteria:
1. Males and females aged 1.5 years or younger with open fontanelles and known or suspected hypoxic ischemic injury.
2. Post menstrual age of 34 weeks or older
3. Patient in the Children's Hospital of Philadelphia (CHOP) Neonatal Intensive Care Unit (NICU) or Pediatric Intensive Care Unit (PICU)
4. Parental permission
Exclusion Criteria:
1. Medical history of Lumason hypersensitivity
2. Hemodynamic instability as defined by rapid escalation of cardiopulmonary support in the past 12-24 hours, as defined by the clinical care team including ≥ 1 intensive care physician not part of the study team
3. Pulmonary insufficiency as defined by fraction of inspired oxygen (FiO2) requirements of \> 40% and/or subjects with pulmonary hypertension requiring nitric oxide
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Minute
Maximum Age:
18 Months
Study:
NCT03549520
Study Brief:
Protocol Section:
NCT03549520