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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT04523935
Eligibility Criteria:
1. A child with cerebral palsy under the age of 15 years and could not communicate the reason for excessive crying because of young age or global developmental delay/profound intellectual retardation.
2. Excessive crying of \>7.5 hours daily for 30 consecutive days unresponsive to treatment by the pediatrician, orthopedic surgeon, gastroenterologist, and physiotherapist.
3. Minimum cry intensity for recording: If the intensity of crying was so high that the caregiver could not hear radio, TV, or another person talking to her \[sitting near her\], the cry duration was recorded.
4. History, clinical, and neuroimaging findings (structural MRI) were suggestive of chronic static encephalopathy.
5. Motor impairment could be explained by an insult that occurred in the developing fetal or infant brain.
Exclusion Criteria:
1. Medicines used in the study were used in the previous 30 days, and it was impossible to taper off the drugs without worsening of symptoms.
2. Excessive crying due to known causes.
3. Progressive encephalopathies.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
15 Years
Study:
NCT04523935
Study Brief:
Protocol Section:
NCT04523935