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 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT06171295
Eligibility Criteria:
Inclusion Criteria:
* Obtained informed consent of parent(s)/legal representative(s)
* Age younger than 45thweek of PMA
* Age older than 25thweek of PMA
* body weight (BW) more than 500g
* Previous or planned operation with great demand on POPM
* Other diseases demanding great POPM (even without any need of surgery)
* Vital functions of the patient will be stable and there will be no suspicion, that patient current condition might be worsen by insertion of c-CELA (every patient will be discussed with attending physician )
Exclusion Criteria:
* Decline of informed consent by parent(s) legal representative
* Age older than 45thweek of PMA
* Age younger than 25th week of PMA
* body weight (BW) lower than 500g
* Congenital malformation of caudal part of spine ( spina bifida occulta , meningocele, meningomyelocele)
* Disease or congenital malformation significantly restricting liver functions (Elevation of liver enzymes more than twice above the physiological range of the corresponding PMA)
* Disease or congenital malformation significantly restricting kidney functions (Elevation of urea and creatinine enzymes more than twice above the physiological range of the corresponding PMA)
* Clinical condition, which doesn't long-term POPM
* Meningism
* Patients with proven withdrawal syndrome caused by opiate administration
* High risk of bleeding during insertion (coagulopathy) or known administrated anticoagulants which might be still active in the time of insertion of c-CELA
* Substantial anemia (under 90g/l), which could lead to blood transfusion due to blood drawing
* frequent blood tests associated with the treatment of the patient(with blood samples necessary for the purposes of the study together), which would exceed maximum
* any hemodynamically unstable condition (for example septic shock)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
5 Weeks
Study:
NCT06171295
Study Brief:
Protocol Section:
NCT06171295