112 CHAPTER 5 Standard protocols, registrations and patient consent Approval of an independent regional ethics committee and registration in the Dutch Trial Register (trialregister.nl identifier: NTR3537) was obtained. Written and informed consent by caregivers or patients was provided for all participants. Role of the funding source The study sponsors had no influence on the study design, collection of data, data analysis, interpretation of data, writing of the report or decision to submit the paper for publication. RESULTS Of the 119 participants who were screened for eligibility, 40 did not meet the inclusion criteria and 22 declined participation, leaving 57 children and adolescents randomized to treatment allocation . Fifty-three participants (mean age 11 years, range 8 - 22 years, SD 2·8 years) were analyzed. One patient crossed over to the BoNT-A arm because the caregivers preferred BoNT-A above 2-DL. Thirtyone children were diagnosed with CP while 22 children had unexplained other neurodevelopmental disabilities ormainly as part of a syndrome (e.g. Dandy–Walker, de Grouchy), genetic (e.g. trisomy 1q), or metabolic disorder. Baseline assessments were obtained at an average of 18 weeks (SD 15 weeks) before intervention. Four children were previously treated with anticholinergics which were stopped due to side effects or lack of effect. Patient characteristics and number of preceding submandibular BoNT-A injections did not differ significantly between the BoNT-A and 2-DL group (table 1).5
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