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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT05205356
Eligibility Criteria:
Inclusion Criteria:
* Newborns presenting with probable genetic conditions inpatient on the NICU. These may include (but is not limited to) those with unexplained hypotonia, seizures, metabolic disorders, disorders of sex development, interstitial lung disease, immunodeficiency or multiple congenital anomalies.
* Babies must have at least one biologic parent available for consent and participation.
* The criteria for inclusion are 100% phenotype based and do not include any demographic parameters.
Exclusion Criteria:
* Presence of a likely nongenetic explanation for the phenotype (e.g., perinatal asphyxia explained by uterine rupture or placental pathology;
* Clinical features pathognomonic for a recognizable chromosomal abnormality, such as trisomy 21;
* Associations already known to have low genetic diagnostic yield, including VATER/VACTERL association and OEIS complex;
* Infants who die before enrollment;
* Known family history of genetic disease that is plausibly the cause of the infant's illness; - Those with a prenatal genetic diagnosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Days
Maximum Age:
99 Years
Study:
NCT05205356
Study Brief:
Protocol Section:
NCT05205356