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 @ 12:53 PM
Ignite Modification Date:
2025-12-24 @ 12:53 PM
NCT ID:
NCT03550261
Eligibility Criteria:
Inclusion Criteria:
* Newborns with confirmation or strong suspicion of diagnosis of congenital adrenal hyperplasia:
* Newborns with abnormal differentiation of the external genitalia, without palpable gonad at birth and high 17 OHP plasma level
* Newborns diagnosed with antenatal CAH,
* Newborns diagnosed at birth with CAH (due to parents at risk of transmission of the disease),
* Newborns diagnosed by systematic screening for 17 OHP on the 3rd day of life (thus having a high dosage of 17 OHP), confirmed by a second sample.
For all these patients the diagnosis of CAH will have to be confirmed secondarily by molecular biology.
Exclusion Criteria:
* Newborn with an anomaly of sexual differentiation from another origin,
* Newborn already under treatment with Fludrocortisone and/or Hydrocortisone.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
15 Days
Study:
NCT03550261
Study Brief:
Protocol Section:
NCT03550261