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:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT01576705
Eligibility Criteria:
Inclusion Criteria:
* patient with a karyotype demonstrating homogeneous, free or Robertsonian translocation trisomy 21
* patient having undergone a cardiac ultrasound not demonstrating any severe heart disease
* patient aged 6 to 18 months at inclusion
Exclusion Criteria:
* congenital hypothyroidism
* hypothyroidism demonstrated by laboratory tests (TSH \> 7mUI/l)
* presenting or having presented hyperthyroidism
* presenting or having presented leukaemia
* presenting or having presented West syndrome or any other form of epilepsy or unstable neurological disease
* presenting or having presented signs of central nervous system distress: stroke, postoperative hypoxia, meningitis)
* presenting severe heart disease on cardiac ultrasound, with haemodynamic effects
* presenting non-controlled cardiac arrhythmia
* Apgar \< 7 to 5 min at birth
* Gestational age \< 231 days (33 gestation weeks)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
18 Months
Study:
NCT01576705
Study Brief:
Protocol Section:
NCT01576705