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The Facial Nerve Palsy And Cortisone Evaluation (FACE) Study in Children: A Randomized Double-blind, Placebo-controlled, Multicenter Trial
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.
Age
1 - 17 years
Sex
ALL
Healthy Volunteers
No
Barn- och ungdomsmedicin
Falun, Dalarna County, Sweden
Barn och ungdomskliniken, Länssjukhuset
Kalmar, Region Kalmar, Sweden
Barnkliniken, Skaraborgs sjukhus
Skövde, Västra Götalands Region, Sweden
Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset
Gothenburg, Sweden
Barn- och ungdomsmedicinska kliniken
Jönköping, Sweden
Barn- och ungdomsmottagning
Karlskrona, Sweden
HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus
Linköping, Sweden
Akutmottagning för barn, Skåne Universitets sjukhus
Lund, Sweden
Barnakuten i Malmö, Skåne Universitets sjukhus
Malmo, Sweden
Barn- och ungdomskliniken, Vrinnevi sjukhuset
Norrköping, Sweden
Start Date
May 3, 2019
Primary Completion Date
August 31, 2026
Completion Date
December 31, 2026
Last Updated
February 21, 2025
500
ESTIMATED participants
Prednisolone
DRUG
Placebo Oral Tablet
DRUG
Lead Sponsor
Dalarna County Council, Sweden
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06542289