Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy

Phase 4

Recruiting

• Conditions: Facial Nerve Diseases; Borrelia Infection of Central Nervous System; Bell Palsy; Facial Palsy
• Interventions: Drug: Placebo Oral Tablet; Drug: Prednisolone

• Registration Number: NCT03781700
• Lead Sponsor: Dalarna County Council, Sweden

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-14
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-20
• Study Start: 2019-05-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Primary Completion: 2026-08-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Oral Tablet	Placebo oral tablet
Prednisolone	Prednisolone	Prednisolone

Primary Outcome Measures

Name	Time	Method
House-Brackmann scale	At 12 months (+/- 2 weeks) after inclusion	Total recovery in the two treatment groups measured with the House-Brackmann scale.; The House-Brackmann scale (I is normal function and VI is total loss of function) is chosen as primary outcome measure since it is an objective instrument, easy to perform and the one most frequently used in previous studies. The time point 12 months for evaluation of total recovery is chosen as no further improvement of the facial nerve function is expected after 12 months.

Secondary Outcome Measures

Name	Time	Method
Sunnybrook facial grading system	At 12 months (+/- 2 weeks) after inclusion	Total recovery in the two treatment groups measured with the Sunnybrook scale.; The Sunnybrook scale (100 is normal function and 0 is total loss of function) is another objective scale for grading the facial nerve function. It will be used as secondary outcome measure. It is easy to perform and has been used in previous studies in children. It correlates well to the House-Brackmann scale.
Facial Disability Index (FDI)	At 12 months (+/- 2 weeks) after inclusion	Disease-specific Quality-of-Life assessment scale, with 5 functional domains (5 means no probelms and 2 or 1 means problems all the time) and 5 social domains (6 means problems all the time and 1 means no problems at all)
Facial Clinimetric Evaluation (FaCE) Scale	At 12 months (+/- 2 weeks) after inclusion	Disease-specific Quality-of-Life assessment scale, with 15 functional and social domains (1 means problems all the time and 5 means no problems at all).
Synkinesis Assessment Questionnaire (SAQ)	At 12 month (+/- 2 weeks) after inclusion	Subjective grading of synkinesis symptoms with 9 functional domains (1 means no problems at all and 5 means problems all the time).

Trial Locations

Locations (15)

Barn- och ungdomsmedicinska kliniken; 🇸🇪 Jönköping, Sweden

HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus; 🇸🇪 Linköping, Sweden

Barn- och ungdomskliniken, Vrinnevi sjukhuset; 🇸🇪 Norrköping, Sweden

Astrid Lindgrens barnsjukhus, Karolinska Solna; 🇸🇪 Solna, Sweden

Barn- och ungdomskliniken, Universitets sjukhuset Örebro; 🇸🇪 Örebro, Sweden

Barn och ungdomskliniken, Länssjukhuset; 🇸🇪 Kalmar, Region Kalmar, Sweden

Astrid Lindgrens barnsjukhus, Karolinska Huddinge; 🇸🇪 Stockholm, Sweden

Sachsska barnsjukhuset; 🇸🇪 Stockholm, Sweden

Barnkliniken, Skaraborgs sjukhus; 🇸🇪 Skövde, Västra Götalands Region, Sweden

Barn- och ungdomsmedicin; 🇸🇪 Falun, Dalarna, Sweden

Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset; 🇸🇪 Göteborg, Sweden

Barn- och ungdomsmottagning; 🇸🇪 Karlskrona, Sweden

Akutmottagning för barn, Skåne Universitets sjukhus; 🇸🇪 Lund, Sweden

Barnakuten i Malmö, Skåne Universitets sjukhus; 🇸🇪 Malmö, Sweden

Akademisk Barnsjukhuset; 🇸🇪 Uppsala, Sweden