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 @ 2:24 PM
Ignite Modification Date:
2025-12-24 @ 2:24 PM
NCT ID:
NCT03234959
Eligibility Criteria:
Inclusion Criteria:
* i) abnormal neurological signs (i.e. neurological signs at the Hammersmith Infant Neurological Assessment -HINE- and according to Prechtl's Assessment GMA) at 2-4 mts post term age
* ii) neuroimaging evidence of brain lesion indicated by MRI performed around the term age (4-6 wks post term)
* iii) achieved predefined motor development scores assessed by Ages and Stages Questionnaire-3
* iv) informed consent agreement
Exclusion Criteria:
* i) Drug resistant seizures,
* ii) Severe sensory deficits (blindness or deafness)
* iii) Progressive neurological disorders
* iv) Malformation of CNS
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
12 Months
Study:
NCT03234959
Study Brief:
Protocol Section:
NCT03234959