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BackgroundDelirium is associated with substantial morbidity and mortality rates in elderly hospitalised patients, and a growing problem due to increase in life expectancy. Implementation of standardised non-pharmacological delirium prevention strategies is challenging and adherence remains low. Pharmacological delirium prevention with haloperidol, currently the drug of choice for delirium, seems promising. However, the generalisability of randomised controlled trial results is questionable since studies have only been performed in selected postoperative hip-surgery and intensive care unit patient populations. We therefore present the design of the multicenter, randomised, double-blind, placebo-controlled clinical trial on early pharmacological intervention to prevent delirium: haloperidol prophylaxis in older emergency department patients (The HARPOON study).Methods/DesignIn six Dutch hospitals, at-risk patients aged 70 years or older acutely admitted through the emergency department for general medicine and surgical specialties are randomised (n = 390) for treatment with prophylactic haloperidol 1 mg or placebo twice daily for a maximum of seven consecutive days. Primary outcome measure is the incidence of in-hospital delirium within seven days of start of the study intervention, diagnosed with the Confusion Assessment Method, and the Diagnostic and Statistical Manual of Mental Disorders, fourth edition criteria for delirium. Secondary outcome measures include delirium severity and duration assessed with the Delirium Rating Scale Revised 98; number of delirium-free days; adverse events; hospital length-of-stay; all-cause mortality; new institutionalisation; (Instrumental) Activities of Daily Living assessed with the Katz Index of ADL, and Lawton IADL scale; cognitive function assessed with the Six-item Cognitive Impairment Test, and the Dutch short form Informant Questionnaire on Cognitive Decline in the Elderly. Patients will be contacted by telephone three and six months post-discharge to collect data on cognitive- and physical function, home residency, all-cause hospital admissions, and all-cause mortality.DiscussionThe HARPOON study will provide relevant information on the efficacy and safety of prophylactic haloperidol treatment for in-hospital delirium and its effects on relevant clinical outcomes in elderly at-risk medical and surgical patients.Trial registrationEudraCT Number: 201100476215; ClinicalTrials.gov Identifier: NCT01530308; Dutch Clinical Trial Registry: NTR3207

Aim To examine the impact of the COVID‐19 pandemic on the mental health of parents of infants with colic and on healthcare use. Methods Retrospective cohort study. Data of 64 parents of infants with colic prepandemic and 43 parents of infants with colic during the pandemic were analysed using validated questionnaires on parental stress, depression and anxiety. Additionally, we evaluated the number of outpatient clinic visits and admission rates pre‐ and during the pandemic by collecting data on the diagnosis treatment combination ‘excessive crying’ from electronic patient files in three secondary hospitals in the Netherlands. Results Mothers in the pandemic group reported significantly higher levels of depression than mothers in the prepandemic group (12.3 ± 7.0 and 8.8 ± 5.2; p = 0.04). Moreover, mothers showed a trend towards higher stress levels during the pandemic (29.6 ± 9.6 and 25.2 ± 8.1; p = 0.06). During the pandemic, admission numbers of infants with colic compared to prepandemic data increased with 34% (146 vs. 196). Conclusion Mothers of infants with colic reported significantly more feelings of depression during the COVID‐19 pandemic. Furthermore, the pandemic was associated with increased healthcare use amongst infants with colic. With the continuing pandemic, we recommend active perinatal support for this vulnerable population.

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