Clinical trial NCT03781700: Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy
Official title: The Facial Nerve Palsy And Cortisone Evaluation (FACE) Study in Children: A Randomized Double-blind, Placebo-controlled, Multicenter Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Facial Palsy
Facial Nerve Diseases
Borrelia Infection of Central Nervous System
Bell Palsy
Keywords: Children
Paediatric
Lead sponsor: Dalarna County Council, Sweden
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2018-12-20
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Acute facial nerve palsy occur in 10-20/100 000 children/year in Sweden. About 20 % of these children will have persistent symptoms with excessive tear secretion, drooling and social problems due to asymmetry in the face. Studies on cortisone treatment to adult patients with acute facial nerve palsy have shown beneficial effects, but no studies with strong quality have been performed in children.

Investigators will perform a double-blind randomized placebo-controlled multicenter trial on children with acute facial nerve palsy. Participants will be recruited consecutively at 9-12 study centers in Sweden during 2019-2020. Oral cortisone (prednisolone) 1 mg/kg x 1 in 10 days (or placebo) will be started on admission. Clinical data, including recovery will be followed-up until 12 months.

The primary outcome is defined as total recovery of the facial nerve palsy, measured with the House-Brackmann scale (grade 1) at 12-months follow-up.

The overall purpose is to assess the utility of cortisone treatment given to children with acute facial nerve palsy in this study. If the total recovery rate is significantly improved in the prednisolone group as compared to the placebo group, prednisolone treatment will be introduced in clinical practice for children with acute facial nerve palsy in order to reduce the risk of persistent symptoms.


Eligibility criteria: Inclusion Criteria:

1. 1-17 years of age
2. Acute peripheral unilateral facial nerve palsy
3. Less than 72 hours since debut of symptoms
4. Signed informed consent

Exclusion Criteria:

1. Head trauma \<1 month
2. Central or bilateral facial nerve palsy
3. Malformations in head and neck
4. Conditions not compatible with cortisone treatment (arterial hypertension, diabetes mellitus, psychiatric disorder, active or latent tuberculosis, intolerance of lactose)
5. Current or past oncological diagnosis
6. Other serious medical conditions (meningitis, encephalitis, stroke)
7. Acute otitis media
8. Signs of herpes simplex or varicella zoster infection (vesicles in the ear region)
9. Pregnancy or breastfeeding
10. Use of any systemic or inhaled steroids within 2 weeks prior onset of symptoms
11. Immunization with live vaccine 1 month prior onset of symptoms
12. Requirement of live vaccine within 2 months from start of experimental treatment (prednisolone or placebo)
13. Evaluation of primary endpoint at 12 months not feasible for any reason
14. Previously included into the FACE study

Primary outcomes:
measure: House-Brackmann scale
timeFrame: At 12 months (+/- 2 weeks) after inclusion
Secondary outcomes:
measure: Sunnybrook facial grading system
timeFrame: At 12 months (+/- 2 weeks) after inclusion
measure: Facial Disability Index (FDI)
timeFrame: At 12 months (+/- 2 weeks) after inclusion
measure: Facial Clinimetric Evaluation (FaCE) Scale
timeFrame: At 12 months (+/- 2 weeks) after inclusion
measure: Synkinesis Assessment Questionnaire (SAQ)
timeFrame: At 12 month (+/- 2 weeks) after inclusion
Other outcomes:
measure: Adverse events
timeFrame: Up to 12 month (+/- 2 weeks) after inclusion
Locations:
city: Falun
country: Sweden
facility: Barn- och ungdomsmedicin
state: Dalarna
city: Kalmar
country: Sweden
facility: Barn och ungdomskliniken, Länssjukhuset
state: Region Kalmar
city: Skövde
country: Sweden
facility: Barnkliniken, Skaraborgs sjukhus
state: Västra Götalands Region
city: Göteborg
country: Sweden
facility: Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset
city: Jönköping
country: Sweden
facility: Barn- och ungdomsmedicinska kliniken
city: Karlskrona
country: Sweden
facility: Barn- och ungdomsmottagning
city: Linköping
country: Sweden
facility: HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus
city: Lund
country: Sweden
facility: Akutmottagning för barn, Skåne Universitets sjukhus
city: Malmö
country: Sweden
facility: Barnakuten i Malmö, Skåne Universitets sjukhus
city: Norrköping
country: Sweden
facility: Barn- och ungdomskliniken, Vrinnevi sjukhuset
city: Solna
country: Sweden
facility: Astrid Lindgrens barnsjukhus, Karolinska Solna
city: Stockholm
country: Sweden
facility: Sachsska barnsjukhuset
city: Stockholm
country: Sweden
facility: Astrid Lindgrens barnsjukhus, Karolinska Huddinge
city: Uppsala
country: Sweden
facility: Akademisk Barnsjukhuset
city: Örebro
country: Sweden
facility: Barn- och ungdomskliniken, Universitets sjukhuset Örebro
Study officials:
affiliation: Center for Clinical Research Dalarna
name: Barbro Hedin Skogman, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Karlsson S, Arnason S, Hadziosmanovic N, Laestadius A, Hultcrantz M, Marsk E, Skogman BH. The facial nerve palsy and cortisone evaluation (FACE) study in children: protocol for a randomized, placebo-controlled, multicenter trial, in a Borrelia burgdorferi endemic area. BMC Pediatr. 2021 May 4;21(1):220. doi: 10.1186/s12887-021-02571-w.