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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT04713657
Eligibility Criteria:
Inclusion Criteria:
* Male and female infants \< 60 days of age with a diagnosis of tetralogy of Fallot (ToF) with pulmonary stenosis (PS) or double outlet right ventricle (DORV), tetralogy type by echocardiogram, who weigh greater than 2 kg at the time of consent and are tolerating enteral feeds.
* DORV variant
Exclusion Criteria:
* congenital atrio-ventricular block on EKG (PR interval \> 120 ms),
* concomitant medication administration that interacts with propranolol,
* patient family is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason,
* gestation age \< 35 weeks,
* infants of diabetic mothers, asthma or underlying respiratory disease,
* presence of metal implants in infants.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Days
Maximum Age:
60 Days
Study:
NCT04713657
Study Brief:
Protocol Section:
NCT04713657