Assessing Response Rates and Sleep Disorder Prevalence: Insights from a Propranolol Treatment Study for Infantile Hemangiomas

Background: Infantile haemangiomas (IH) may require treatment with propranolol. Sleep disturbances are the most fre-quently reported side effects. Monitoring drug adverse events necessitates repeated hospital visits, despite the SARS-CoV-2 pandemic. Objectives: To explore the effectiveness of a new electronic questionnaire in identifying sleep disturbances as adverse events to treatment and potential confounders. To evaluate the response rate to the questionnaire. To report the propor-tion of patients on propranolol with sleep disturbances. Methods: In an observational, prospective cohort study, caregivers provided clinical information at office visits and via an electronic questionnaire after an 8-week treatment course and at treatment interruption. Adverse drug reaction (ADR) reporting forms were evaluated for causality assessment. Results: The questionnaire response rate was 91%, and the completion rate was 100%. The prevalence of sleep disturb-ances as adverse reactions was 59%. Sleep disorders were more frequent during sleep regression phases and in subjects who fell asleep with physical contact with caregivers or bed-sharing with parents. Conclusion: The application of this questionnaire allows for identifying sleep-adverse events associated with propranolol in IH and potential confounders. Counselling on sleep hygiene is recommended before treatment onset