Diagnostics and intrathecal treatment of pediatric patients with leukemia Not Applicable
Conditions
Interventions
Patients' lumbar puncture procedures are alternately performed either with the IQ-Tip system (study arm A) or the conventional spinal needle (study arm B). The maximum number of procedures per patient
Sponsors
Injeq Plc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 1 and 18 years old at the beginning of the study 2. Diagnosis or treatment plan requires multiple lumbar puncture procedures for collecting cerebrospinal fluid samples and injecting intrathecal therapy 3. Planned lumbar puncture procedures will be performed with 22G Quincke-type spinal needles 4. At least two lumbar puncture procedures left in the patient’s treatment protocol 5. Both the parent(s) and the patient, depending on the patient’s age, give a signed informed consent before the first study lumbar puncture procedure
Exclusion criteria
Exclusion criteria: 1. Parent(s) and/or the patient refuse to participate in the trial 2. Parent(s) and/or the patient are considered unable to give informed consent 3. Temporary contraindication to performing a lumbar puncture procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of traumatic lumbar puncture measured as the proportion of traumatic lumbar punctures (threshold >/= 10 erythrocytes/µl in a cerebrospinal fluid sample) out of all lumbar puncture procedures performed in the given arm after the data collection of the study is completed | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. First puncture success rate measured as the proportion of successful lumbar puncture procedures at the first attempt (one skin penetration) out of all lumbar puncture procedures performed in the given arm after the data collection of the study is completed 2. Incidence of post-dural puncture headache (PDPH) measured as the proportion of lumbar puncture procedures with subsequent PDPH out of all lumbar puncture procedures performed in the given arm after the data collection of the study is completed | — |
Countries
Finland
Outcome results
None listed