Clinical trial NCT06579235: Explorative Proteomics in Pediatric Neuroborreliosis
Official title: Explorative Proteomics to Ease the Diagnosis of Pediatric Neuroborreliosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Neuroborreliosis
Facial Palsy
Pediatric Infectious Disease
Keywords: Neuroborreliosis
Pediatric Infectious Disease
Proteomics
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Clinical Proteomics, Department of Clinical Biochemistry, Bispebjerg Hospital
name: NNF Center for Protein Research, University of Copenhagen
First posted: 2024-08-30
Enrollment: 106
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All children aged 1 month to 17 years presenting at pediatric wards in the capital region of Denmark with facial nerve palsy and/or suspicion of lyme neuroborreliosis.

Brief summary: This study aims to use proteomic analysis to diagnose Lyme Neuroborreliosis (LNB) in children. Pediatric patients with suspected LNB will be enrolled, and their blood samples will be collected for proteomic analyses. Mass spectrometry will be used to compare protein profiles of LNB-positive and LNB-negative patients. The data will be analyzed by bioinformaticians. The expected impact is to establish a non-invasive, reliable method for early LNB diagnosis to improve patient outcomes.

Detailed description: Objective:

The primary objective of this study is to investigate the utility of proteomic analysis in diagnosing lyme neuroborreliosis (LNB) in children. By identifying specific protein markers associated with LNB (proteomics), the investigators aim to enhance early detection and improve patient outcomes.

Methods:

Participant Recruitment:

The investigators will enroll pediatric patients (aged 1 month to 17 years) presenting with suspected LNB.

Informed consent will be obtained from parents or legal guardians.

Sample Collection:

Peripheral blood samples will be collected from each participant in EDTA tubes. Samples will be processed to carry out proteomic analyses.

Proteomic Analysis:

Mass spectrometry will be employed to compare protein profiles between LNB-positive and LNB-negative patients.

Data Analysis and Presentations:

Protein profiles will be analysed by trained bioinformaticians and mainly presented in volcano plots and heat maps.

Outcome Measures:

Unique proteomic profiles of children with LNB.

Expected Impact:

This study aims to establish a non-invasive and reliable method for diagnosing LNB in children. Early identification will facilitate timely treatment and prevent complications associated with LNB.

Eligibility criteria: Inclusion Criteria:

* Presenting at a pediatric ward with facial nerve palsy and/or suspicion of lyme neuroborreliosis
* Parental informed consent

Exclusion Criteria:

* Parents or legal guardians unable to understand given information or comply with study criteria
* Patient unable to cooperate to study procedures (blood sample)
* Unclear etiology after lumbar puncture

Primary outcomes:
measure: Protein concentrations
timeFrame: An average of 2 years from enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Department of Children and Adolescents
Study officials:
References: