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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT04253951
Eligibility Criteria:
Inclusion Criteria:
* cerebral palsy or abnormal muscular tone at any age between 0-3 years of life due disorders other than cerebral palsy;
* motor developmental delay assessed by a quantitative scale for infants and young children development (\<5 sd according to age)
* in absence of the previous clinical indices, if there is the clinical suspicion of GERD or dysphagia based on clinical symptoms
* a brain MRI acquisition done before or programmed prior the end of the study period as part of their diagnostic procedure.
Exclusion Criteria:
* epileptic spasm
* drugs for muscle tone abnormalities or GERD introduced or modified less than 3 weeks before potential enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Weeks
Maximum Age:
6 Years
Study:
NCT04253951
Study Brief:
Protocol Section:
NCT04253951