Actively Recruiting

Phase 4
Age: 1Year - 17Years
All Genders
NCT03781700

Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy

Led by Dalarna County Council, Sweden · Updated on 2025-02-21

500

Participants Needed

15

Research Sites

399 weeks

Total Duration

On this page

Sponsors

D

Dalarna County Council, Sweden

Lead Sponsor

K

Karolinska Institutet

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy

Who Can Participate

Age: 1Year - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 1 to 17 years
  • Acute peripheral unilateral facial nerve palsy
  • Symptoms started less than 72 hours ago
  • Signed informed consent provided
Not Eligible

You will not qualify if you...

  • Head trauma within the past month
  • Central or bilateral facial nerve palsy
  • Head or neck malformations
  • Conditions incompatible with cortisone treatment such as high blood pressure, diabetes, psychiatric disorders, active or latent tuberculosis, or lactose intolerance
  • Current or past cancer diagnosis
  • Serious medical conditions like meningitis, encephalitis, or stroke
  • Acute middle ear infection
  • Signs of herpes simplex or varicella zoster infection (vesicles in the ear area)
  • Pregnancy or breastfeeding
  • Use of systemic or inhaled steroids within 2 weeks before symptom onset
  • Live vaccine within 1 month before symptom onset
  • Need for live vaccine within 2 months after starting study treatment
  • Unable to complete 12-month follow-up evaluation
  • Previously participated in the FACE study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

Barn- och ungdomsmedicin

Falun, Dalarna County, Sweden, 79131

Actively Recruiting

2

Barn och ungdomskliniken, Länssjukhuset

Kalmar, Region Kalmar, Sweden, S-391 85

Actively Recruiting

3

Barnkliniken, Skaraborgs sjukhus

Skövde, Västra Götalands Region, Sweden, S-541 85

Actively Recruiting

4

Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset

Gothenburg, Sweden

Actively Recruiting

5

Barn- och ungdomsmedicinska kliniken

Jönköping, Sweden, 55185

Actively Recruiting

6

Barn- och ungdomsmottagning

Karlskrona, Sweden, 37185

Actively Recruiting

7

HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus

Linköping, Sweden, 58585

Actively Recruiting

8

Akutmottagning för barn, Skåne Universitets sjukhus

Lund, Sweden, 22185

Actively Recruiting

9

Barnakuten i Malmö, Skåne Universitets sjukhus

Malmö, Sweden, 20502

Actively Recruiting

10

Barn- och ungdomskliniken, Vrinnevi sjukhuset

Norrköping, Sweden, S-601 82

Actively Recruiting

11

Barn- och ungdomskliniken, Universitets sjukhuset Örebro

Örebro, Sweden, S-70185

Actively Recruiting

12

Astrid Lindgrens barnsjukhus, Karolinska Solna

Solna, Sweden, 71764

Actively Recruiting

13

Sachsska barnsjukhuset

Stockholm, Sweden, 11883

Actively Recruiting

14

Astrid Lindgrens barnsjukhus, Karolinska Huddinge

Stockholm, Sweden, 14186

Actively Recruiting

15

Akademisk Barnsjukhuset

Uppsala, Sweden, 75185

Actively Recruiting

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Research Team

B

Barbro Hedin Skogman, MD, PhD

CONTACT

S

Sofia Karlsson, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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