Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Facial Palsy, Facial Nerve Diseases, Borrelia Infection of Central Nervous System, Bell Palsy

In brief

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.

Key facts

Study ID

NCT03781700

Run by

Dalarna County Council, Sweden

People needed

500

Starts

2019-05-03

Expected to finish

2026-12-31

Last updated by the study team

2025-02-21

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Barn- och ungdomsmedicin — Falun, Dalarna County, Sweden (enrolling)
• Barn och ungdomskliniken, Länssjukhuset — Kalmar, Region Kalmar, Sweden (enrolling)
• Barnkliniken, Skaraborgs sjukhus — Skövde, Västra Götalands Region, Sweden (enrolling)
• Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset — Gothenburg, Sweden (enrolling)
• Barn- och ungdomsmedicinska kliniken — Jönköping, Sweden (enrolling)
• Barn- och ungdomsmottagning — Karlskrona, Sweden (enrolling)
• HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus — Linköping, Sweden (enrolling)
• Akutmottagning för barn, Skåne Universitets sjukhus — Lund, Sweden (enrolling)
• Barnakuten i Malmö, Skåne Universitets sjukhus — Malmö, Sweden (enrolling)
• Barn- och ungdomskliniken, Vrinnevi sjukhuset — Norrköping, Sweden (enrolling)
• Barn- och ungdomskliniken, Universitets sjukhuset Örebro — Örebro, Sweden (enrolling)
• Astrid Lindgrens barnsjukhus, Karolinska Solna — Solna, Sweden (enrolling)
• Sachsska barnsjukhuset — Stockholm, Sweden (enrolling)
• Astrid Lindgrens barnsjukhus, Karolinska Huddinge — Stockholm, Sweden (enrolling)
• Akademisk Barnsjukhuset — Uppsala, Sweden (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.