Background: Early childhood caries is considered one of the most prevalent diseases in childhood, affecting almost half of preschool-age children globally. In the Netherlands, approximately one-third of children aged 5 years already have dental caries, and dental care providers experience problems reaching out to these children. Objective: Within the proposed trial, we aim to test the hypothesis that, compared to children who receive usual care, children who receive the Toddler Oral Health Intervention as add-on care will have a reduced cumulative caries incidence and caries incidence density at the age of 48 months. Methods: This pragmatic, 2-arm, individually randomized controlled trial is being conducted in the Netherlands and has been approved by the Medical Ethics Research Board of University Medical Center Utrecht. Parents with children aged 6 to 12 months attending 1 of the 9 selected well-baby clinics are invited to participate. Only healthy children (ie, not requiring any form of specialized health care) with parents that have sufficient command of the Dutch language and have no plans to move outside the well-baby clinic region are eligible. Both groups receive conventional oral health education in well-baby clinics during regular well-baby clinic visits between the ages of 6 to 48 months. After concealed random allocation of interventions, the intervention group also receives the Toddler Oral Health Intervention from an oral health coach. The Toddler Oral Health Intervention combines behavioral interventions of proven effectiveness in caries prevention. Data are collected at baseline, at 24 months, and at 48 months. The primary study endpoint is cumulative caries incidence for children aged 48 months, and will be analyzed according to the intention-to-treat principle. For children aged 48 months, the balance between costs and effects of the Toddler Oral Health Intervention will be evaluated, and for children aged 24 months, the effects of the Toddler Oral Health Intervention on behavioral determinants, alongside cumulative caries incidence, will be compared. Results: The first parent-child dyads were enrolled in June 2017, and recruitment was finished in June 2019. We enrolled 402 parent-child dyads. Conclusions: All follow-up interventions and data collection will be completed by the end of 2022, and the trial results are expected soon thereafter. Results will be shared at international conferences and via peer-reviewed publication.
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Het doel van de klinische forensische zorg, of meer specifiek de tbs-maatregel, is het beveiligen van de maatschappij; op korte termijn door iemand uit de maatschappij te halen en op langere termijn door behandeling gericht op het verlagen van risicofactoren en het opbouwen of versterken van beschermende factoren. In de media verschijnen met enige regelmaat kritische verhalen over de forensische zorg, meestal naar aanleiding van een ernstig incident, zoals een delict gepleegd door een tbs-patiënt op verlof. De vraag die daarbij steeds wordt opgeworpen, is hoe effectief de tbs-maatregel en behandeling in de forensische zorg is. Het is logisch dat er maatschappelijke onrust ontstaat bij ernstige incidenten en de opgeworpen vragen vanuit de maatschappij zijn terecht. Toch is enige nuancering hier op zijn plaats, aangezien recidive tijdens forensische behandeling uitzonderlijk is. Zo werd in een recent onderzoek met gegevens van het Adviescollege Verloftoetsing tbs (AVT) gevonden dat slechts bij 0,15% van de 15.050 positief beoordeelde verlofaanvragen sprake was van een ongeoorloofde afwezigheid met recidive. Verder blijkt al jaren uit onderzoek van het Wetenschappelijk Onderzoek- en Datacentrum (WODC) dat ernstige recidive na ontslag uit de forensische zorg, met name de tbs, relatief laag is, in ieder geval aanzienlijk lager dan na een gevangenisstraf. Hierbij dient aangetekend te worden dat de cijfers lastig te vergelijken zijn vanwege belangrijke verschillen tussen de groepen. De recidivecijfers tijdens en na forensische zorg zijn dus relatief gunstig, maar een delict kan enorme impact hebben en het zo veel mogelijk voorkomen van recidive blijft het ultieme doel van de behandeling in de forensische zorg. Het is nog onduidelijk wat precies bijdraagt aan recidivereductie en hoe behandeleffectiviteit of behandelsucces gedefinieerd kan worden.
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BACKGROUND: Prophylaxis for gastrointestinal stress ulceration is frequently given to patients in the intensive care unit (ICU), but its risks and benefits are unclear.METHODS: In this European, multicenter, parallel-group, blinded trial, we randomly assigned adults who had been admitted to the ICU for an acute condition (i.e., an unplanned admission) and who were at risk for gastrointestinal bleeding to receive 40 mg of intravenous pantoprazole (a proton-pump inhibitor) or placebo daily during the ICU stay. The primary outcome was death by 90 days after randomization.RESULTS: A total of 3298 patients were enrolled; 1645 were randomly assigned to the pantoprazole group and 1653 to the placebo group. Data on the primary outcome were available for 3282 patients (99.5%). At 90 days, 510 patients (31.1%) in the pantoprazole group and 499 (30.4%) in the placebo group had died (relative risk, 1.02; 95% confidence interval [CI], 0.91 to 1.13; P=0.76). During the ICU stay, at least one clinically important event (a composite of clinically important gastrointestinal bleeding, pneumonia, Clostridium difficile infection, or myocardial ischemia) had occurred in 21.9% of patients assigned to pantoprazole and 22.6% of those assigned to placebo (relative risk, 0.96; 95% CI, 0.83 to 1.11). In the pantoprazole group, 2.5% of patients had clinically important gastrointestinal bleeding, as compared with 4.2% in the placebo group. The number of patients with infections or serious adverse reactions and the percentage of days alive without life support within 90 days were similar in the two groups.CONCLUSIONS: Among adult patients in the ICU who were at risk for gastrointestinal bleeding, mortality at 90 days and the number of clinically important events were similar in those assigned to pantoprazole and those assigned to placebo. (Funded by Innovation Fund Denmark and others; SUP-ICU ClinicalTrials.gov number, NCT02467621 .).
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