Critical Illness Clinical Trial
— NCIPEDOfficial title:
Incidence and Severity of Neurocognitive Impairment in Pediatric Patients With Meningoencephalitis and Sepsis-associated Encephalopathy
NCT number | NCT04467762 |
Other study ID # | A 2020-0160 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 3, 2020 |
Est. completion date | October 31, 2022 |
Verified date | November 2022 |
Source | University of Rostock |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Neurocognitive impairment is frequently observed in pediatric patients with meningoencephalitis (ME) and sepsis-associated encephalopathy (SAE) which represent two relevant central nervous system (CNS) diseases in pediatric patients. It is uncertain, if the the origin of the disease, located primarily in the CNS of patients with ME or secondarily in patients with SAE in the course of sepsis, is of importance for the severity of injury to the brain. Prospective clinical studies combining clinical and laboratory examinations including specific biomarkers of neuroaxonal injury were not performed in a comparative study. Biomarkers of neuroaxonal injury are therefore not only of great interest to detect and monitor neurocognitive impairment but also to quantify the severity of brain injury in patients with ME and SAE.
Status | Completed |
Enrollment | 42 |
Est. completion date | October 31, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 17 Years |
Eligibility | Inclusion Criteria: - pediatric patients between 1 day and 17 years of age - admission to hospital with suspected meningoencephalitis or sepsis <24 hours after admission or time of diagnosis - admission to hospital for minor surgery (herniotomy, osteosynthesis, adenoidectomy) Exclusion Criteria: - preexisting central nervous system diseases (stroke, hemorrhage, tumor, traumatic brain injury, brain surgery, epilepsy, hydrocephalus) - preexisting immunosuppression - participation in another interventional study - no written informed consent from parents or legal representative |
Country | Name | City | State |
---|---|---|---|
Germany | University Medical Center Rostock | Rostock |
Lead Sponsor | Collaborator |
---|---|
University of Rostock |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of delirium/neurocognitive impairment in pediatric patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy | Assessment of neurocognitive impairment using validated tools | Day 90 | |
Primary | Change in neuroaxonal injury biomarker levels in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy | Measurement of biomarker levels (e.g. NSE, S100B, neurofilament proteins) derived from blood and cerebrospinal fluid samples | Change from baseline biomarker levels at day 5 | |
Primary | Neurocognitive 3-months outcome in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy | Assessment of the neurocognitive performance of patients using validated tests (e.g. pediatric cerebral performance category) | Day 90 | |
Secondary | 90-day survival in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy | Survival after 90 days | Day 90 | |
Secondary | Length of hospital stay in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy | Cumulative days in hospital | 1 year | |
Secondary | Length of intensive care unit stay in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy | Cumulative days on intensive care unit | 1 year |
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