Facial ParalysisNCT01537952
Microbiologic Findings of Acute Facial Palsy in Children
An observational study of Facial Paralysis, run by University of Helsinki.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Facial Paralysis
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Tertiary university Hospital, children 0-16 years old
Who may be able to join
- Age 0-16
- Facial palsy
Who cannot join
None listed.
About this study
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.
- Conditions
- Facial Paralysis
- Keywords
- facial paralysis, facial nerve, borreliosis, Bell's palsy
- Medical subject headings
- Facial Paralysis, Borrelia Infections, Bell Palsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startMay 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facial ParalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Principal investigator, Mervi Kanerva, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537952
- Sponsor's protocol ID
- 230419
- Status last verified
- Feb 2012
- First submitted
- 18 Feb 2012
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23657208
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiologic Findings of Acute Facial Palsy in Children
- ClinicalTrials.gov ID
- NCT01537952
- Acronym / sponsor ID
- 230419
- Conditions
- Facial Paralysis
- Keywords
- facial paralysis, facial nerve, borreliosis, Bell's palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Study start
- May 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 23 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Tertiary university Hospital, children 0-16 years old
Key inclusion criteria (2 listed)
- Age 0-16
- Facial palsy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2012.
- Derived from this study: PubMed 23657208Kanerva 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Paralysis, run by University of Helsinki.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01537952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2012.