Thesis

113 Surgery vs botulinum for the impact of drooling on daily life in children with neurodevelopmental disabilities: a randomized controlled trial 5 Table 1 Baseline demographic and clinical characteristics (intention-to-treat population) BoNT-A (n = 26) 2-DL (n = 27) P-value Age, y, mean ± SD 11·2 ± 2·5 11·1 ± 3·2 0·93 Female sex, n (%) 11 (42·3%) 11 (40·7%) 0·91 Main diagnosis (%) 0·46 Spastic CP 10 (38·5%) 6 (22·2%) Dyskinetic CP 1 (3·8%) 3 (11·1%) Spastic / dyskinetic CP 5 (19·2%) 5 (18·5%) CP, type is missing 1 (3·8%) 0 Other nonprogressive neurodevelopmental disorder a 9 (34·6%) 13 (48·1%) GMFCS levelb (n = 31) n (%) n=17 n=14 0·33 II 2 (11·8%) 1 (7·1%) III 3 (17·6%) 0 IV 5 (29·4%) 8 (57·1%) V 7 (41·2%) 5 (35·7%) Mobility, n (%) 0·70 Ambulant 11 (42·3%) 10 (37%) Non-ambulant 15 (57·7%) 17 (63%) Estimated developmental age, n (%) 0·88 <4 y 15 (57·7%) 15 (55·6%) ≥4 y 11 (42·3%) 12 (44·4%) Epilepsy, n (%) 0·47 Yes 17 (65·4%) 15 (55·6%) Controlled 13 (76·5%) 13 (86·7%) 0·66 Intractable 4 (23·5%) 2 (13·3%) No 9 (34·6%) 12 (44·4%) Gastrostomy feeding, n (%) 0·33 Oral 16 (61·5%) 20 (74·1%) Gastrostomy/gastrostomy and oral (no pharyngeal swallowing problem) 10 (38·5%) 7 (25·9%) Underwent BoNT-A pre-trial, n (%) 0·70 No 11 (42·3%) 10 (37%) Yes 15 (57·7%) 17 (63%) Mean number of received submandibular BoNT-A injections ± SD 1·6 ± 1·8 1·4 ± 1·3 0·19 Mean years since last BoNT-A injection ± SD 1·1 ± 0·7 2·0 ± 2·8 0·26 BoNT-A, botulinum neurotoxin type A; 2-DL, 2-duct ligation; SD, Standard Deviation; CP, Cerebral Palsy; GMFCS, Gross Motor Function Classification System; GMFCS I – III is classified as Ambulant; GMFCS IV –V is classified as Non-ambulant. A p-value of <0·05 was considered statistically significant. a Disorders mainly based on a syndrome (Pitt-Hopkins, cri du chats, distal 18q-, Sjögren-Larsson, Marden-Walker, ATR-x), genetic (deletions or trisomy) or metabolic (mitochondrial) disorder. b Only applicable in children with CP (n=31)

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