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Table 1 Inclusion and exclusion criteria

From: 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

Inclusion criteria
 1. 1–17 years of age
 2. Acute peripheral unilateral facial nerve palsy
 3. Symptom duration < 72 h
 4. Signed informed consent
Exclusion criteria
 1. Head trauma < 1 month
 2. Central facial palsy
 3. Malformations of the head and neck
 4. Conditions incompatible with corticosteroid treatment (arterial hypertension, diabetes mellitus type 1, 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 corticosteroids within 2 weeks prior symptom onset
 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/placebo)
 13. Evaluation of primary endpoint at 12 months not feasible for any reason
 14. Previously included into the FACE study