185 Hydrocortisone as an intervention (RCT) 6 ALL-11 MR patients n=256 Eligible patients n=123 InformedConsen t n=79 Enrolled patients n=79 Neurobehavioral problems n=52 (66%) Randomized Controlled Trial n=52 No neurobehavioral problems n=27 (34%) PlaceboHydrocortisone n=26 HydrocortisonePlacebo n=26 Assessed for primary endpoint n=25 Assessed for primary endpoint n=26 Exclusionn=133 (52%) - Still on doxorubicin: n=21 - Age (<3 or >18): n=19 - Hydrocortisoneuse: n=17 - No/less dexamethasone: n=17 - Language barrier: n=14 - Inclusionrelated study: n=12 - Mental retardation: n=9 - Rarelyin the Máxima: n=7 - No permission oncologist: n=5 - Risperidoneuse: n=4 - Deceased: n=2 - Other: n=6 Refusal n=44 (36%) - Burden: n=11 - No time: n=6 - Few side effects: n=10 - No extra medication: n=4 - Too many studies: n=3 - Not interested: n=2 - Other: n=5 - Unknown: n=3 Dropout: 0 Dropout: 1 Figure 2. CONSORT flow diagram ALL patients were screened on our in- and exclusion criteria and after approval of the treating pediatric oncologist approached for inclusion. Reasons for refusal are what parents or patients themselves reported. After enrollment, patients were measured during a ‘dexamethasone only’ course. Patients with clinically significant neurobehavioral problems were subsequently included in the randomized controlled trial. Due to one dropout 26 children who started with hydrocortisone and 25 children who started with placebo were assessed for our primary endpoint. Abbreviations: ALL: acute lymphoblastic leukemia, MR: medium risk
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