NCT01537952

Brief Summary

Objective: Microbiologic etiologies of facial palsy in children were investigated. Study design: Prospective clinical study. Methods: Forty-six children aged 0-16 years with facial palsy comprised the study group. Paired serum samples and cerebrospinal fluid were tested to find indications (antibodies, growth of the microbe, or nucleic acids) of microbes putatively associated with facial palsy. The microbes tested were herpes simplex virus-1 and -2, varicella-zoster virus, human herpesvirus-6, Mycoplasma pneumoniae, Borrelia burgdorferi, influenza A and B-, picorna-, cytomegalo-, parainfluenza-, respiratory syncytial-, coxsackie B5-, adeno-, and enteroviruses, Chlamydia psittaci, and Toxoplasma gondii. Besides the routine tests in clinical practice, serum and cerebrospinal fluid samples were tested with a highly sensitive microarray assay for DNA of herpes simplex virus-1 and -2, human herpesvirus-6A , -6B, -7, Epstein-Barr-, cytomegalo-, and varicella-zoster viruses.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2007

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
Last Updated

February 23, 2012

Status Verified

February 1, 2012

Enrollment Period

2.3 years

First QC Date

February 18, 2012

Last Update Submit

February 22, 2012

Conditions

Facial Paralysis

Keywords

facial paralysis, facial nerve, borreliosis, Bell's palsy

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Tertiary university Hospital, children 0-16 years old

You may qualify if:

  • Age 0-16
  • Facial palsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kanerva M, Nissinen J, Moilanen K, Maki M, Lahdenne P, Pitkaranta A. Microbiologic findings in acute facial palsy in children. Otol Neurotol. 2013 Sep;34(7):e82-7. doi: 10.1097/MAO.0b013e318289844c.

    PMID: 23657208DERIVED

MeSH Terms

Conditions

Facial ParalysisBorrelia InfectionsBell Palsy

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesFacial Nerve DiseasesCranial Nerve Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 18, 2012

First Posted

February 23, 2012

Study Start

May 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

February 23, 2012

Record last verified: 2012-02