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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT05161169
Eligibility Criteria:
Inclusion Criteria:
Infant participants
* Has not previously had exome or genome sequencing
* Age 0-12 months
* Seen for well-baby pediatric care at a recruiting site
* Primary healthcare provider completed the genomics education program
* At least one parent or guardian able to participate in the study
Parent participants
* Biological parent or legal guardian of an infant participating in the study
* 18 years of age or older
* Unimpaired decision-making capacity
* English or Spanish speaking
* Available to have genetic counseling and provide consent for testing the infant
Exclusion Criteria:
* Parents are unwilling to have genomic reports placed in the medical record or sent to their primary care pediatrician
* Any infant in which clinical considerations preclude collecting blood via heel stick
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
0 Months
Maximum Age:
12 Months
Study:
NCT05161169
Study Brief:
Protocol Section:
NCT05161169