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Model-Informed Once-Daily Dosing Strategy for Bedaquiline and Delamanid in Children, Adolescents and Adults with Tuberculosis.
Clin Pharmacol Ther
December 2024
Department of Pharmacy, Uppsala University, Uppsala, Sweden.
The complexity of the currently registered dosing schedules for bedaquiline and delamanid is a barrier to uptake in drug-resistant tuberculosis treatment across all ages. A simpler once-daily dosing schedule is critical to ensure patient-friendly regimens with good adherence. We assessed expected drug exposures with proposed once-daily doses for adults and compared novel model-informed once-daily dosing strategies for children with current World Health Organization (WHO) recommended dosing.
View Article and Find Full Text PDFImproving outcomes for very preterm babies in England: does place of birth matter? Findings from OPTI-PREM, a national cohort study.
Arch Dis Child Fetal Neonatal Ed
December 2024
Nuffield Department of Population Health, University of Oxford National Perinatal Epidemiology Unit, Oxford, UK.
Objective: Babies born between 27 and 31 weeks of gestation contribute substantially towards infant mortality and morbidity. In England, their care is delivered in maternity services colocated with highly specialised neonatal intensive care units (NICU) or less specialised local neonatal units (LNU). We investigated whether birth setting offered survival and/or morbidity advantages to inform National Health Service delivery.
View Article and Find Full Text PDFEvaluation of the Efficacy and Accuracy of Super-Flexible Three-Dimensional Heart Models of Congenital Heart Disease Made via Stereolithography Printing and Vacuum Casting: A Multicenter Clinical Trial.
J Cardiovasc Dev Dis
December 2024
Department of Pediatric Cardiology, National Cerebral and Cardiovascular Center, Suita 564-8565, Japan.
Three-dimensional (3D) printing is an advanced technology for accurately understanding anatomy and supporting the successful surgical management of complex congenital heart disease (CHD). We aimed to evaluate whether our super-flexible 3D heart models could facilitate preoperative decision-making and surgical simulation for complex CHD. The super-flexible heart models were fabricated by stereolithography 3D printing of the internal and external contours of the heart from cardiac computed tomography (CT) data, followed by vacuum casting with a polyurethane material similar in elasticity to a child's heart.
View Article and Find Full Text PDFAssessing the Use and Acceptability of Virtual Reality to Assist Coping in Children Undergoing Clinical Procedures.
J Spec Pediatr Nurs
January 2025
Department of Anesthesia and Pain Medicine, Perth Children's Hospital, Perth, Western Australia, Australia.
Purpose: Virtual reality is used as a distraction tool during medical procedures that can cause anxiety and pain. We assessed the usefulness, engagement, value and feasibility of virtual reality to help children cope with routine clinical procedures.
Design And Methods: Quality improvement study.
A Phase I Dose-Finding Design Incorporating Intra-Patient Dose Escalation.
Pharm Stat
December 2024
Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Conventional Phase I trial designs assign a single dose to each patient, necessitating a minimum number of patients per dose to reliably identify the maximum tolerated dose (MTD). However, in many clinical trials, such as those involving pediatric patients or patients with rare cancers, recruiting an adequate number of patients can pose challenges, limiting the applicability of standard trial designs. To address this challenge, we propose a new Phase I dose-finding design, denoted as IP-CRM, that integrates intra-patient dose escalation with the continual reassessment method (CRM).
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