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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT02757794
Eligibility Criteria:
Inclusion Criteria:
* Already included in the study EPIPAGE 2, born between 24 and 34 weeks' GA (gestational amenorrhea),
* Children aged 5 to 6 years,
* Children exhibiting a total intellectual quotient \>70 from the WPPSI IV (during the 5-year assessment in EPIPAGE 2),
* Children having a visuo-spatial Working Memory impairment defined by a working memory index \<85 from the WPPSI IV,
* Children with parents (or legal guardians) authorizing participation in the study and a signed informed consent form,
* Children affiliated with medical insurance.
Exclusion Criteria:
* Children with severe cerebral palsy, based on the Gross Motor Function (GMFCS score \>2) and Bimanual Fine Motor Function (BFMF \>2) classification system (Elvrum AG 2015, Marois P 2015),
* Children with blindness or amblyopia, defined by a visual acuity \<3 (during the 5-year assessment in EPIPAGE 2),
* Children with deafness, as defined by a prescribed hearing aid,
* Children with chromosomal disorder or autistic syndrome,
* Children included in the EPILANG study protocol (an ancillary project to EPIPAGE),
* Children who do not speak French
* Children with parents having no internet connection,
* Triplets.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
6 Years
Study:
NCT02757794
Study Brief:
Protocol Section:
NCT02757794