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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004187-35 | EudraCT Number |
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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisolone | Experimental | Prednisolone |
|
| Placebo | Placebo Comparator | Placebo oral tablet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug | Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| House-Brackmann scale | 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. | At 12 months (+/- 2 weeks) after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Sunnybrook facial grading system | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of Adverse Events possibly or probably related to the study drug. | Up to 12 month (+/- 2 weeks) after inclusion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbro Hedin Skogman, MD, PhD | Contact | +46 (0)23 49 20 00 | barbro.hedinskogman@regiondalarna.se | |
| Sofia Karlsson, MD | Contact | +46 (0)23 49 20 00 | sofia.a.karlsson@regiondalarna.se |
| Name | Affiliation | Role |
|---|---|---|
| Barbro Hedin Skogman, MD, PhD | Center for Clinical Research Dalarna | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barn- och ungdomsmedicin | Recruiting | Falun | Dalarna County | 79131 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33947355 | Derived | Karlsson S, Arnason S, Hadziosmanovic N, Laestadius A, Hultcrantz M, Marsk E, Skogman BH. The facial nerve palsy and cortisone evaluation (FACE) study in children: protocol for a randomized, placebo-controlled, multicenter trial, in a Borrelia burgdorferi endemic area. BMC Pediatr. 2021 May 4;21(1):220. doi: 10.1186/s12887-021-02571-w. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 4, 2021 | Aug 23, 2021 |
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Randomized controlled trial
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| Placebo Oral Tablet | Drug | Placebo tablets with identical appearance to the experimental drug |
|
|
| At 12 months (+/- 2 weeks) after inclusion |
| Facial Disability Index (FDI) | 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) | At 12 months (+/- 2 weeks) after inclusion |
| Facial Clinimetric Evaluation (FaCE) Scale | 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). | At 12 months (+/- 2 weeks) after inclusion |
| Synkinesis Assessment Questionnaire (SAQ) | Subjective grading of synkinesis symptoms with 9 functional domains (1 means no problems at all and 5 means problems all the time). | At 12 month (+/- 2 weeks) after inclusion |
| Barn och ungdomskliniken, Länssjukhuset | Recruiting | Kalmar | Region Kalmar | S-391 85 | Sweden |
|
| Barnkliniken, Skaraborgs sjukhus | Recruiting | Skövde | Västra Götalands Region | S-541 85 | Sweden |
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| Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset | Recruiting | Gothenburg | Sweden |
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| Barn- och ungdomsmedicinska kliniken | Recruiting | Jönköping | 55185 | Sweden |
|
| Barn- och ungdomsmottagning | Recruiting | Karlskrona | 37185 | Sweden |
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| HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus | Recruiting | Linköping | 58585 | Sweden |
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| Akutmottagning för barn, Skåne Universitets sjukhus | Recruiting | Lund | 22185 | Sweden |
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| Barnakuten i Malmö, Skåne Universitets sjukhus | Recruiting | Malmö | 20502 | Sweden |
|
| Barn- och ungdomskliniken, Vrinnevi sjukhuset | Recruiting | Norrköping | S-601 82 | Sweden |
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| Barn- och ungdomskliniken, Universitets sjukhuset Örebro | Recruiting | Örebro | S-70185 | Sweden |
|
| Astrid Lindgrens barnsjukhus, Karolinska Solna | Recruiting | Solna | 71764 | Sweden |
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| Sachsska barnsjukhuset | Recruiting | Stockholm | 11883 | Sweden |
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| Astrid Lindgrens barnsjukhus, Karolinska Huddinge | Recruiting | Stockholm | 14186 | Sweden |
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| Akademisk Barnsjukhuset | Recruiting | Uppsala | 75185 | Sweden |
|
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 20, 2022 | Aug 22, 2022 | SAP_002.pdf |
| ID | Term |
|---|---|
| D005158 | Facial Paralysis |
| D005155 | Facial Nerve Diseases |
| D020330 | Bell Palsy |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003389 | Cranial Nerve Diseases |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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