44 CHAPTER 2 the study, one inclusion criterion was changed due to insufficient inclusion: the requirement for previous treatment with BoNT-A prior to inclusion was dropped. Also, the minimum age of inclusion was raised from 6 years to 8 years to give each child maximum opportunity to develop. Both changes were approved by the regional ethics committee. The study was partially blinded: 8- and 32-week followup Drooling Quotient (DQ) measurements were recorded on video. A separate speech language therapist blinded to therapy allocation measured the DQ using these video recordings. Study design. This interventional, randomized, controlled trial for drooling in children and adolescents with neurodevelopmental disabilities, was conducted in Nijmegen, The Netherlands between April 2012 and August 2017. Standard protocol approvals, registrations, and patient consents. This study was performed following approval from an independent regional ethics committee and was registered in the Dutch Trial Register (trialregister.nl identifier NTR3537). Written informed consent was obtained from all guardians of the participants in the study. Participants. Patients were seen at the regular outpatient Saliva Control clinic of the Radboud University Medical Centre and were assessed for eligibility by our Saliva Control team including a pediatric neurologist, a pediatric speech-language therapist, a rehabilitation specialist and an Ear- Nose- and Throat surgeon. Children who reported severe drooling, and where conservative treatment had failed or was not expected to provide adequate relief, were eligible for inclusion. All patients who were cognitively capable underwent oral therapy to maximize mouth closure. Patients were enrolled by the study coordinator. To prevent a carry-over effect, interventions only took place 6 months after the last previous treatment. Inclusion criteria were as follows: 1. Severe drooling (Drooling Frequency Score ≥ 3 or Drooling Severity Score ≥ 2).15 2. Aged 8 years and older. 3. Cerebral palsy or any other non-progressive neurodevelopmental disability.
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