Condition: Facial Palsy · Facial Nerve Diseases · Borrelia Infection of Central Nervous System · Sponsor: Dalarna County Council, Sweden
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.
This description comes directly from the study's public registry record.
Barbro Hedin Skogman, MD, PhD · +46 (0)23 49 20 00 · barbro.hedinskogman@regiondalarna.se
Sofia Karlsson, MD · +46 (0)23 49 20 00 · sofia.a.karlsson@regiondalarna.se
Always discuss trial participation with your own doctor first.
| Barn- och ungdomsmedicin | Falun, Dalarna County, Sweden | Recruiting |
| Barn och ungdomskliniken, Länssjukhuset | Kalmar, Region Kalmar, Sweden | Recruiting |
| Barnkliniken, Skaraborgs sjukhus | Skövde, Västra Götalands Region, Sweden | Recruiting |
| Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset | Gothenburg, Sweden | Recruiting |
| Barn- och ungdomsmedicinska kliniken | Jönköping, Sweden | Recruiting |
| Barn- och ungdomsmottagning | Karlskrona, Sweden | Recruiting |
| HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus | Linköping, Sweden | Recruiting |
| Akutmottagning för barn, Skåne Universitets sjukhus | Lund, Sweden | Recruiting |
| Barnakuten i Malmö, Skåne Universitets sjukhus | Malmö, Sweden | Recruiting |
| Barn- och ungdomskliniken, Vrinnevi sjukhuset | Norrköping, Sweden | Recruiting |
| Barn- och ungdomskliniken, Universitets sjukhuset Örebro | Örebro, Sweden | Recruiting |
| Astrid Lindgrens barnsjukhus, Karolinska Solna | Solna, Sweden | Recruiting |
+ 3 more locations — full list on the registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT03781700