Bells Palsy RCT
Bells Palsy – Multicentre Randomised Controlled Trial
It is unclear if children with Bell’s palsy should be treated with corticosteroids or not and consequently guidelines are vague and practice is variable regarding steroid use. The Bells Palsy Randomised Controlled Trial aims to determine the efficacy of prednisolone as a treatment for Bell’s palsy in children less than 18 years of age, presenting to Emergency Departments within the PREDICT network. The multicentre randomised and placebo controlled trial will be conducted over a four year period. As the first appropriately powered trial of steroid use in children with Bell’s palsy the study will likely have a worldwide impact on the management of this important yet treatable condition in this vulnerable population.
Study design
Multicentre, randomised placebo controlled trial
Franz Babl (Royal Children’s Hospital; Murdoch Children’s Research Institute)
Timeframe
2015 – 2019
Funding
National Health and Medical Research Council
Emergency Medicine Foundation
- Starship Children’s Hospital, New Zealand
- Royal Children’s Hospital, Melbourne, Australia
- Monash Children’s Hospital, Victoria, Australia.
- Children’s Hospital at Westmead, Sydney, Australia
- John Hunter Hospital, Newcastle, Australia.
- Women’s and Children’s Hospital, Adelaide, Australia
- Sunshine Hospital, Melbourne, Australia.
- Lady Cilento Children’s Hospital, South Brisbane, Queensland, Australia
- Princess Margaret Hospital for Children, Perth, Western Australia
- Gold Coast Hospital, Queensland, Australia
- Townsville Hospital, Queensland, Australia
- Logan Hospital, Queensland, Australia
Sample
270 children with Bell ’s palsy will be randomised to each group
Clinical trials registrations
Click here
Contact
Publications to date
Babl FE, Kochar A, Osborn M, Borland ML, West A, Williams A, Dalziel SR; PREDICT network. Risk of Leukemia in Children With Peripheral Facial Palsy. Ann Emerg Med. 2020 Aug 9:S0196-0644(20)30491-1.
doi: 10.1016/j.annemergmed.2020.06.029. Online ahead of print. PMID: 32788067. [link].
Babl FE, Mackay M, Dalziel SR. Letters to the Editor: Facial nerve palsy in children, J Paediatr Child Health, 55 (2019) 878-879. DOI: 10.1111/jpc.14494. [link].
Babl FE, Gardiner KK, Kochar A, Wilson CL, George SA, Zhang M, Furyk J, Thosar D, Cheek JA, Krieser D, Rao AS, Borland ML, Cheng N, Phillips NT, Sinn KK, Neutze JM, Dalziel SR, PREDICT (Paediatric Research In Emergency Departments International Collaborative) Bell’s palsy in children: Current treatment patterns in Australia and New Zealand. A PREDICT study. J Paediatr Child Health. 2017 Feb 8. doi: 10.1111/jpc.13463. [link]
Xiong X, Huang L, Herd DW, Borland ML, Davidson A, Hearps S, Mackay MT, Lee KJ, Dalziel SR, Dalziel K, Cheek JA, Babl FE. Cost-effectiveness of Prednisolone to Treat Bell Palsy in Children: An Economic Evaluation Alongside a Randomized Controlled Trial. Neurology. 2023 Jun 13;100(24):e2432-e2441. doi: 10.1212/WNL.0000000000207284. Epub 2023 Apr 18. PMID: 37072220 Clinical Trial. [Link]
Babl FE, Eapen N, Herd D, Borland ML, Kochar A, Zhang M, Oakley E, Hopper SM, Berkowitz RG, Wilson CL, Williams A, Mackay MT, Lee KJ, Hearps S; PREDICT (Paediatric Research in Emergency Departments International Collaborative) research network. Agreement of Clinician-Administered and Modified Parent-Administered House-Brackmann Scales in Children with Bell’s Palsy. OTO Open. 2023 Mar 24;7(1):e44. doi: 10.1002/oto2.44. eCollection 2023 Jan-Mar. PMID: 36998545 Free PMC article. [Link]
Williams A, Eapen N, Kochar A, Lawton B, Hort J, West A, George S, Berkowitz R, Lee KJ, Dalziel SR, Hearps S, Babl FE; PREDICT (Paediatric Research in Emergency Departments International Collaborative) research network. Agreement Between House-Brackmann and Sunnybrook Facial Nerve Grading Systems in Bell’s Palsy in Children: Secondary Analysis of a Randomized, Placebo-Controlled Multicenter Trial. J Child Neurol. 2023 Feb;38(1-2):44-51. doi: 10.1177/08830738221144082. Epub 2023 Feb 5. PMID: 36740927 Clinical Trial. [Link]
Babl FE, Herd D, Borland M, Kochar A, Lawton B, Hort J, West A, George S, Zhang M, Velusamy K, Sullivan F, Oakley E, Davidson A, Hopper SM, Cheek JA, Berkowitz R, Hearps S, Wilson CL, Williams A, Elborough H, Legg D, Pharm B, Mackay MT, Lee KJ, Dalziel SR; Paediatric Research in Emergency Departments International Collaborative (PREDICT). Efficacy of Prednisolone for Bell Palsy in Children: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Neurology. 2022 Aug 25:10.1212/WNL.0000000000201164. doi: 10.1212/WNL.0000000000201164. Online ahead of print. [Link]
Babl FE, Mackay MT, Borland ML, Herd DW, Kochar A, Hort J, Rao A, Cheek JA, Furyk J, Barrow L, George S, Zhang M, Gardiner K, Lee KJ, Davidson A, Berkowitz R, Sullivan F, Porrello E, Dalziel KM, Anderson V, Oakley E, Hopper S, Williams F, Wilson C, Williams A, Dalziel SR; PREDICT (Paediatric Research In Emergency Departments International Collaborative) research network. Bell’s Palsy in Children (BellPIC): Protocol for a Multicentre, Placebo-Controlled Randomized Trial. BMC Pediatrics 2017 Feb 13;17(1):53. doi: 10.1186/s12887-016-0702-y. [Link]
Babl FE, West A, Borland M et al. Risk of Leukemia in Children with Peripheral Facial Palsy. Ann Emerg Med. 2020 Aug 9:S0196-0644(20)30491-1. doi: 10.1016/j.annemergmed.2020.06.029. PMID: 32788067. [Epub ahead of print]. [Link]
Babl FE, Herd D, Borland ML, Kochar A, Lawton B, Hort J, West A, George S, Oakley E, Wilson CL, Hopper SM, Cheek JA, Hearps S, Mackay MT, Dalziel SR, Lee KJ. Facial Function in Bell’s Palsy in a Cohort of Children Randomized to Prednisolone or Placebo 12 months after Diagnosis. Pediatric Neurology. Published online 2024 Jan 11, Volume 153, Pages 44-47,. ISSN 0887-8994. https://doi.org/10.1016/j.pediatrneurol.2024.01.011. [Link]