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

NCT04467762 | Completed

• 1 other identifier: A 2020-0160
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Critical Illness; Brain Injuries; Encephalopathy; Delirium; Inflammatory Disease; Central Nervous System Diseases

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• 90-day survival in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy

  Day 90

• Length of hospital stay in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy

  1 year

• Length of intensive care unit stay in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy

  1 year

Study Arms (3)

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

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rostock: lead

Study Sites (1)

University Medical Center Rostock

Rostock, 18059, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and cerebrospinal fluid samples

MeSH Terms

Conditions

Critical Illness; Brain Injuries; Brain Diseases; Delirium; Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Johannes Ehler, MD

  University of Rostock

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: August 3, 2020
• Primary Completion: December 31, 2021
• Study Completion: October 31, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)