Neurocognitive Impairment in Pediatric Patients With Meningoencephalitis and Sepsis-associated Encephalopathy (NCIPED)

November 1, 2022 updated by: Dr. Johannes Ehler, MD, University of Rostock

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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:

  1. Patients with ME (primary CNS infection) indicate a higher incidence and severity of neurocognitive impairment than patients with SAE (secondary CNS affection)
  2. Specific biomarkers of neuroaxonal injury in blood and CSF correlate with the clinical severity of neurocognitive impairment in patients with ME and SAE
  3. Specific biomarkers of neuroaxonal injury in blood and CSF correlate with the 3-months neurocognitive outcome of patients with ME and SAE

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Rostock, Germany, 18059
        • University Medical Center Rostock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 90
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
Change from baseline biomarker levels at day 5
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)
Day 90

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
90-day survival in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy
Time Frame: Day 90
Survival after 90 days
Day 90
Length of hospital stay in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy
Time Frame: 1 year
Cumulative days in hospital
1 year
Length of intensive care unit stay in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy
Time Frame: 1 year
Cumulative days on intensive care unit
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rostock

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A 2020-0160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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