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:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT01724593
Eligibility Criteria:
Inclusion Criteria:
* Age over 12 months to 17 years
* PCCU stay of ≥ 48 hours
* Patient is limited to bed-rest and has not been mobilized during the first 48 hours of PCCU admission
* Equal to or greater than one organ dysfunction on PCCU admission (as measured by PELOD)
* Informed consent of patient/substitute decision maker.
Exclusion Criteria:
* Age: \< 12 months or ≥18 years
* Patients admitted to step-down/intermediate care
* Patients transferred from Neonatal intensive care unit and never discharge home.
iv) Patients who are already mobilizing well, or are at baseline functional status at time of screening v) Admission diagnosis of a neuromuscular disorder: e.g. Acute Guillain-Barré Syndrome, Botulism, Myasthenia Gravis), or acute spinal cord injury/transverse myelitis vi) Not expected to survive PCCU/hospital stay vii) Previously enrolled into study less than 6 months ago and/or still undergoing study procedures at time of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
17 Years
Study:
NCT01724593
Study Brief:
Protocol Section:
NCT01724593