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 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT04330859
Eligibility Criteria:
Inclusion Criteria:
* GA at birth: ≤32 weeks gestation and/or birthweight ≤1500 grams
* Infants 7 days or older
* Ability of parents or identified designated surrogate (e.g. grandparent) to perform the interventions
* Abnormal writhing GMs defined by the presence of a poor repertoire pattern on 2 consecutive assessments or the presence of a cramped-synchronized pattern on any assessment
Exclusion Criteria:
* Clinically unstable (requiring high frequency mechanical ventilation, vasopressor support, need for continuous intravenous pain or sedation medication)
* If their parents do not speak English
* If parental participation is hindered (e.g. incarceration).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
23 Weeks
Maximum Age:
32 Weeks
Study:
NCT04330859
Study Brief:
Protocol Section:
NCT04330859