Critical IllnessNCIPEDNCT04467762
Neurocognitive Impairment in Pediatric Patients With Meningoencephalitis and Sepsis-associated Encephalopathy
An observational study of Critical Illness and Brain Injuries, run by University of Rostock at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Critical Illness, Brain Injuries, Encephalopathy
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 3 Aug 2020to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: All pediatric patients who are admitted to the study center will be screened for study eligibility according to the inclusion and exclusion criteria.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence and Severity of Neurocognitive Impairment in Pediatric Patients With Meningoencephalitis and Sepsis-associated Encephalopathy
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.
Read the detailed description
This is a prospective single-center observational study evaluating the incidence and severity of the neurocognitive impairment in pediatric patients with meningoencephalitis (ME) and sepsis-associated encephalopathy (SAE). All study participants will be assessed by clinical and neurological examination as well as comprehensive laboratory tests using biomarkers of neuroaxonal injury at study day 1 (day of study inclusion), day 3 and day 5. A panel of biomarkers derived from blood and cerebrospinal fluid (CSF) samples (among others NSE, S100B and neurofilament proteins) will be measured. Clinical assessment will be performed using validated scales of severity of disease (e.g. pSOFA score) and validated delirium tests (among others pGCS, pCAM-ICU) to assess the neurocognitive performance of study participants before and three months after study inclusion (among others POPC/PCPC).
A matched group of pediatric patients without evidence for ME or sepsis/SAE will serve as a control group and will undergo the same clinical and laboratory examinations except CSF analysis.
The investigators hypothesize, that:
- Patients with ME (primary CNS infection) indicate a higher incidence and severity of neurocognitive impairment than patients with SAE (secondary CNS affection)
- Specific biomarkers of neuroaxonal injury in blood and CSF correlate with the clinical severity of neurocognitive impairment in patients with ME and SAE
- Specific biomarkers of neuroaxonal injury in blood and CSF correlate with the 3-months neurocognitive outcome of patients with ME and SAE
- Conditions
- Critical Illness, Brain Injuries, Encephalopathy, Delirium, Inflammatory Disease, Central Nervous System Diseases
- Medical subject headings
- Critical Illness, Brain Injuries, Brain Diseases, Delirium, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Meningoencephalitis (ME-PED) | * pediatric patients between 0 and 17 years of age * admission to hospital with suspected meningoencephalitis * confirmed meningoencephalitis within 24 hours after admission | |
| Sepsis-associated encephalopathy (SAE-PED) | * pediatric patients between 0 and 17 years of age * admission to hospital with suspected sepsis * confirmed sepsis within 24 hours after admission or time of diagnosis | |
| Control group (CON-PED) | * pediatric patients between 0 and 17 years of age * exclusion of neurocognitive impairment * admission to hospital for minor surgery (e.g. herniotomy, adenoidectomy, fractures treated by osteosynthesis) or for hemangioma treated by propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium/neurocognitive impairment in pediatric patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy
Assessment of neurocognitive impairment using validated tools
Measured: Day 90
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
Measured: Change from baseline biomarker levels at day 5
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)
Measured: Day 90
Secondary outcomes (3)
90-day survival in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy
Survival after 90 days
Measured: Day 90
Length of hospital stay in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy
Cumulative days in hospital
Measured: 1 year
Length of intensive care unit stay in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy
Cumulative days on intensive care unit
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start3 Aug 2020
- Primary completion31 Dec 2021
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Johannes Ehler, MD, University of Rostock
- Investigators
- Johannes Ehler, MD, Principal investigator, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467762
- Sponsor's protocol ID
- A 2020-0160
- Acronym
- NCIPED
- Status last verified
- Nov 2022
- First submitted
- 8 Jul 2020
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Severity of Neurocognitive Impairment in Pediatric Patients With Meningoencephalitis and Sepsis-associated Encephalopathy
- ClinicalTrials.gov ID
- NCT04467762
- Acronym / sponsor ID
- NCIPED / A 2020-0160
- Conditions
- Critical Illness, Brain Injuries, Encephalopathy, Delirium, Inflammatory Disease, Central Nervous System Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective single-center observational study evaluating the incidence and severity of the neurocognitive impairment in pediatric patients with meningoencephalitis (ME) and sepsis-associated encephalopathy (SAE). All study participants will be assessed by clinical and neurological examination as well as comprehensive laboratory tests using biomarkers of neuroaxonal injury at study day 1 (day of study inclusion), day 3 and day 5. A panel of biomarkers derived from blood and cerebrospinal fluid (CSF) samples (among others NSE, S100B and neurofilament proteins) will be measured. Clinical assessment will be performed using validated scales of severity of disease (e.g. pSOFA score) and validated delirium tests (among others pGCS, pCAM-ICU) to assess the neurocognitive performance of study participants before and three months after study inclusion (among others POPC/PCPC).
A matched group of pediatric patients without evidence for ME or sepsis/SAE will serve as a control group and will undergo the same clinical and laboratory examinations except CSF analysis.
The investigators hypothesize, that:
- Patients with ME (primary CNS infection) indicate a higher incidence and severity of neurocognitive impairment than patients with SAE (secondary CNS affection)
- Specific biomarkers of neuroaxonal injury in blood and CSF correlate with the clinical severity of neurocognitive impairment in patients with ME and SAE
- Specific biomarkers of neuroaxonal injury in blood and CSF correlate with the 3-months neurocognitive outcome of patients with ME and SAE
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meningoencephalitis (ME-PED) | – | –* pediatric patients between 0 and 17 years of age * admission to hospital with suspected meningoencephalitis * confirmed meningoencephalitis within 24 hours after admission |
| Sepsis-associated encephalopathy (SAE-PED) | – | –* pediatric patients between 0 and 17 years of age * admission to hospital with suspected sepsis * confirmed sepsis within 24 hours after admission or time of diagnosis |
| Control group (CON-PED) | – | –* pediatric patients between 0 and 17 years of age * exclusion of neurocognitive impairment * admission to hospital for minor surgery (e.g. herniotomy, adenoidectomy, fractures treated by osteosynthesis) or for hemangioma treated by propranolol |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All pediatric patients who are admitted to the study center will be screened for study eligibility according to the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of delirium/neurocognitive impairment in pediatric patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy
Time frame: Day 90
Assessment of neurocognitive impairment using validated tools
Change in neuroaxonal injury biomarker levels in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy
Time frame: Change from baseline biomarker levels at day 5
Measurement of biomarker levels (e.g. NSE, S100B, neurofilament proteins) derived from blood and cerebrospinal fluid samples
Neurocognitive 3-months outcome in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy
Time frame: Day 90
Assessment of the neurocognitive performance of patients using validated tests (e.g. pediatric cerebral performance category)
3 secondary outcomes
90-day survival in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy
Time frame: Day 90
Length of hospital stay in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy
Time frame: 1 year
Length of intensive care unit stay in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Ehler, MD principal investigator
University of Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Brain Injuries, run by University of Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium/neurocognitive impairment in pediatric patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy (time frame: Day 90). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.