RecruitingPhase 4NCT03781700

Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy

The Facial Nerve Palsy And Cortisone Evaluation (FACE) Study in Children: A Randomized Double-blind, Placebo-controlled, Multicenter Trial


Sponsor

Dalarna County Council, Sweden

Enrollment

500 participants

Start Date

May 3, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 YearMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether cortisone (a steroid medication) can help children recover faster and more completely from sudden facial nerve palsy — a condition where one side of the face droops unexpectedly, similar to Bell's palsy in adults. Facial palsy can be frightening for children and families, and while most cases improve on their own, treatment with steroids may speed up recovery. However, less is known about the best treatment approach specifically for children. The study is a randomized controlled trial where children will receive either cortisone or a placebo, and their recovery will be tracked over 12 months. It is open to children aged 1 to 17 years who have had sudden one-sided facial nerve palsy within the past 72 hours. You may be eligible if: - Your child is between 1 and 17 years old - Your child has an acute, one-sided (peripheral) facial nerve palsy - Symptoms started less than 72 hours ago You may NOT be eligible if: - Your child has had a head injury within the last month - Your child has bilateral (both-sided) facial palsy or a central cause - Your child has conditions that prevent cortisone use (e.g., diabetes, hypertension, active tuberculosis) - Your child has a current or past cancer diagnosis - Your child has signs of herpes infection in or around the ear - Your child is pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPrednisolone

Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day.

DRUGPlacebo Oral Tablet

Placebo tablets with identical appearance to the experimental drug


Locations(15)

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

Malmö, Sweden

Barn- och ungdomskliniken, Vrinnevi sjukhuset

Norrköping, Sweden

Barn- och ungdomskliniken, Universitets sjukhuset Örebro

Örebro, Sweden

Astrid Lindgrens barnsjukhus, Karolinska Solna

Solna, Sweden

Sachsska barnsjukhuset

Stockholm, Sweden

Astrid Lindgrens barnsjukhus, Karolinska Huddinge

Stockholm, Sweden

Akademisk Barnsjukhuset

Uppsala, Sweden

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NCT03781700


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