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 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT02392195
Eligibility Criteria:
Inclusion Criteria:
1. \- DP requiring helmet therapy
2. -Term gestation at birth (37 weeks or greater)
3. -Less than/or equal to 8 months of age
4. -No history of major health problem such as birth injury, genetic disorder, intracranial hemorrhage, hydrocephalus, neurologic abnormality
5. -No history of implantable metal device or internal/external orthotic device
Exclusion Criteria:
1. \- DP not requiring helmet therapy
2. -Premature gestation at birth (less than 37 weeks gestation).
3. -Greater than 8 months of age
4. -History of major health problem such as birth injury genetic disorder, intracranial hemorrhage, hydrocephalus, neurologic abnormality
5. -History of implantable metal device or internal/external orthotic device
6. -Infants not completing prescribed treatment for correction with a helmet
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
8 Months
Study:
NCT02392195
Study Brief:
Protocol Section:
NCT02392195