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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT02519335
Eligibility Criteria:
Inclusion Criteria:
* age 6 months and under
* open heart surgery requiring CPB and use of cardioplegia
* parent/guardian consent for study obtained surgery planned Monday to Friday
Exclusion Criteria:
* gestational age \<36weeks
* known syndrome or genetic abnormality, except Trisomy 21 single ventricle physiology
* concurrent enrollment in another research protocol
* no parental/guardian consent obtained
* ECMO utilization prior to surgery or necessary at the time of ICU admission
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
6 Months
Study:
NCT02519335
Study Brief:
Protocol Section:
NCT02519335