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

NCT ID: NCT04467762

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-03
• Study Completion Date: 2022-10-31

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.

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

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rostock

OTHER

Sponsor Role: lead

Responsible Party

Dr. Johannes Ehler, MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johannes Ehler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rostock

Locations

University Medical Center Rostock

Rostock, , Germany

Countries

Germany

Other Identifiers

A 2020-0160

Identifier Type: -

Identifier Source: org_study_id