Actively Recruiting
Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy
Led by Dalarna County Council, Sweden · Updated on 2025-02-21
500
Participants Needed
15
Research Sites
399 weeks
Total Duration
On this page
Sponsors
D
Dalarna County Council, Sweden
Lead Sponsor
K
Karolinska Institutet
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 1 to 17 years
- Acute peripheral unilateral facial nerve palsy
- Symptoms started less than 72 hours ago
- Signed informed consent provided
You will not qualify if you...
- Head trauma within the past month
- Central or bilateral facial nerve palsy
- Head or neck malformations
- Conditions incompatible with cortisone treatment such as high blood pressure, diabetes, psychiatric disorders, active or latent tuberculosis, or lactose intolerance
- Current or past cancer diagnosis
- Serious medical conditions like meningitis, encephalitis, or stroke
- Acute middle ear infection
- Signs of herpes simplex or varicella zoster infection (vesicles in the ear area)
- Pregnancy or breastfeeding
- Use of systemic or inhaled steroids within 2 weeks before symptom onset
- Live vaccine within 1 month before symptom onset
- Need for live vaccine within 2 months after starting study treatment
- Unable to complete 12-month follow-up evaluation
- Previously participated in the FACE study
AI-Screening
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Trial Site Locations
Total: 15 locations
1
Barn- och ungdomsmedicin
Falun, Dalarna County, Sweden, 79131
Actively Recruiting
2
Barn och ungdomskliniken, Länssjukhuset
Kalmar, Region Kalmar, Sweden, S-391 85
Actively Recruiting
3
Barnkliniken, Skaraborgs sjukhus
Skövde, Västra Götalands Region, Sweden, S-541 85
Actively Recruiting
4
Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset
Gothenburg, Sweden
Actively Recruiting
5
Barn- och ungdomsmedicinska kliniken
Jönköping, Sweden, 55185
Actively Recruiting
6
Barn- och ungdomsmottagning
Karlskrona, Sweden, 37185
Actively Recruiting
7
HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus
Linköping, Sweden, 58585
Actively Recruiting
8
Akutmottagning för barn, Skåne Universitets sjukhus
Lund, Sweden, 22185
Actively Recruiting
9
Barnakuten i Malmö, Skåne Universitets sjukhus
Malmö, Sweden, 20502
Actively Recruiting
10
Barn- och ungdomskliniken, Vrinnevi sjukhuset
Norrköping, Sweden, S-601 82
Actively Recruiting
11
Barn- och ungdomskliniken, Universitets sjukhuset Örebro
Örebro, Sweden, S-70185
Actively Recruiting
12
Astrid Lindgrens barnsjukhus, Karolinska Solna
Solna, Sweden, 71764
Actively Recruiting
13
Sachsska barnsjukhuset
Stockholm, Sweden, 11883
Actively Recruiting
14
Astrid Lindgrens barnsjukhus, Karolinska Huddinge
Stockholm, Sweden, 14186
Actively Recruiting
15
Akademisk Barnsjukhuset
Uppsala, Sweden, 75185
Actively Recruiting
Research Team
B
Barbro Hedin Skogman, MD, PhD
CONTACT
S
Sofia Karlsson, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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