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 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT02042235
Eligibility Criteria:
Inclusion Criteria:
* Child born at 24 to 31+6 weeks' gestation, whose parents did not refuse collection of follow-up data
* Child aged 30 ± 2 months corrected age (CA) at inclusion
* Child with language delay at 24 months CA, defined as the absence of word combination and/or expressive vocabulary of less than 30 words according to the short version of the French Mac Arthur Communication Developmental Inventories (CDI), whose language delay is confirmed at 30 months CA i.e. without word combination and/or an expressive vocabulary below the 10th percentile on the French CDI.
* Child with a global Developmental Quotient (DQ) ≥ 55 at 30 months CA
* Child whose parents accept participation in this study
* Child with French health insurance coverage
Exclusion Criteria:
* Child with neurological sequelae (delay or disability) and who is unable to walk without assistance at 24 months CA or who has a global DQ \< 55 on the revised Brunet-Lézine (BLR) scale at 30 months CA.
* Blindness
* Deafness defined by the prescription of a hearing aid
* Child with a chromosomal or other condition that could interfere with language development
* Parents who do not speak French at all
* Triplets
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
28 Months
Maximum Age:
32 Months
Study:
NCT02042235
Study Brief:
Protocol Section:
NCT02042235