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

Critical Illness Clinical Trial

— NCIPED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04467762
• Other study ID #: A 2020-0160
• Status: Completed
• Start date: August 3, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries
• Central Nervous System Diseases
• Critical Illness
• Delirium
• Encephalopathy
• Inflammatory Disease
• Meningoencephalitis
• Nervous System Diseases
• Sepsis-Associated Encephalopathy

Locations

Country	Name	City	State
Germany	University Medical Center Rostock	Rostock

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

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