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NCT Number: NCT04467762

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.

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Key information

Conditions

Critical Illness Brain Diseases Brain Injuries Central Nervous System Diseases Confusion Craniocerebral Trauma Delirium Disease Attributes Encephalopathy Inflammatory Disease Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

1 day–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Rostock

Rostock, 18059, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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)

Secondary outcomes

  1. 90-day survival in patients with meningoencephalitis compared to patients with sepsis-associated encephalopathy

    Time frame: Day 90

    Survival after 90 days

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

    Time frame: 1 year

    Cumulative days in hospital

  3. 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

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Registry information

Official study title

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

Acronym: NCIPED

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 13, 2020
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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