Bell’s Palsy in Children (BellPIC): protocol for a multicentre, placebo-controlled randomized trial

BMC Pediatrics

Table 2 Assessment Schedule BellPIC Study

Procedure	Enrolment & Randomisation Time point 1	Time point 2	Time point 3	Time point 4	Time point 5	Time point 6
Procedure	Day 1	Day 14^a	Month 1^b	Month 3^b	Month 6^b	Month 12^d
Obtain Informed consent	✓
Collect demographic and relevant information	✓
Facial images	✓		✓	✓	✓
House Brackmann [18, 27] & Sunnybrook [32, 38] scales augmented with SAQ [48]	✓		✓	✓	✓
Review inclusion & exclusion criteria	✓
Randomise	✓
Study drug dispense	✓
Study drug compliance review		✓	✓
Adverse events review		✓	✓^e
Specialist clinician review			✓^c
Emotional and functional impact using PedsQL, CHU-9D and Harter scales [39–44]			✓	✓	✓
Assessment of pain (VAS/FPS-R) [45–47]			✓	✓	✓
Participant and parent perception of recovery (lay translation of HB scale)		✓	✓	✓	✓	✓
Collection of information on medical attendances			✓	✓	✓

HB House Brackmann scale, SAQ Synkinesis Assessment Questionnaire, PedsQL Pediatric Quality of Life inventory, CHU-9D Child Health Utility 9D, VAS Visual Analogue Scale, FPS-R Faces Pain Scale Revised
^aThis assessment will be conducted over the telephone or on-line. A window of ±5 days is allowed
^bA window of ± 7 days will be allowed to facilitate appointment scheduling for the study assessments attended on-site at 1 month; a window of ±14 days will be allowed to facilitate appointment scheduling or follow up contacts by phone, email or online for study visits or contacts at 3 and 6 months. Once a participant has been assessed to have made a complete recovery (HB score of 1), they will no longer be required to attend further visits to the study clinic and will only be required to complete questionnaires and scales by telephone, email or online at 3 and 6 months
^cThe senior specialist clinician may be a pediatric neurologist; ENT specialist; pediatrician; or ED physician
^dThis assessment will be required only for those deemed to have been not recovered at their 6 month assessment. A window of ±14 days will be allowed to facilitate follow up contacts scheduling
^eAdverse events which are unresolved at 1 month should be followed till resolution or stabilisation

ISSN: 1471-2431