Growth parameters in children with achondroplasia: A 7-year, prospective, multinational, observational study.

PURPOSE: This study was undertaken to collect baseline growth parameters in children with achondroplasia who might enroll in interventional trials of vosoritide, and to establish a historical control. METHODS: In this prospective, observational study, participants (≤17 years) underwent a detailed medical history and physical examination and were followed every 3 months until they finished participating in the study by enrolling in an interventional trial or withdrawing. RESULTS: A total of 363 children were enrolled (28 centers, 8 countries). Mean (SD) follow up was 20.4 (15.0) months. In participants <1 year, mean annualized growth velocity (AGV) was 11.6 cm/year for girls and 14.6 cm/year for boys. By age 1 year, mean AGV decreased to 7.4 cm/year in girls and 7.1 cm/year in boys. By age 10 years, mean AGV decreased to 3.6 cm/year for both sexes. Mean height z-score in participants <1 year was -2.5 for girls and -3.2 for boys and decreased up to the age 5 years (-5.3 for girls; -4.6 for boys). Girls and boys had a disproportionate upper-to-lower body segment ratio. Mean ratio was highest in participants aged <1 year (2.9 for girls; 2.8 for boys) and decreased gradually to approximately 2 in both sexes from 4 years of age onward. CONCLUSION: This study represents one of the largest datasets of prospectively collected medical and longitudinal growth data in children with achondroplasia. It serves as a robust historical control to measure therapeutic interventions against and to further delineate the natural history of this condition.

Assessment of Citrinin in Spices and Infant Cereals Using Immunoaffinity Column Clean-Up with HPLC-Fluorescence Detection.

Historically, the analysis of citrinin has mainly been performed on cereals such as red yeast rice; however, in recent years, more complex and abnormal commodities such as spices and infant foods are becoming more widely assessed. The aim of this study was to develop and validate clean-up methods for spices and cereal-based infant foods using a citrinin immunoaffinity column before HPLC analysis with fluorescence detection. Each method developed was validated with a representative matrix, spiked at various citrinin concentrations, based around European Union (EU) regulations set for ochratoxin A (OTA), with recoveries >80% and % RSD < 9% in all cases. The limit of detection (LOD) and the limit of quantification (LOQ) were established at 1 and 3 µg/kg for spices and 0.1 and 0.25 µg/kg for infant cereals, respectively. These methods were then tested across a variety of spices and infant food products to establish efficacy with high recoveries >75% and % RSD < 5% across all matrices assessed. Therefore, these methods proved suitable for providing effective clean-up of spices and infant cereals, enabling reliable quantification of citrinin detected. Samples such as nutmeg and infant multigrain porridge had higher levels of citrinin contamination than anticipated, indicating that citrinin could be a concern for public health. This highlighted the need for close monitoring of citrinin contamination in these commodities, which may become regulated in the future.

Analysis of Aflatoxins and Ochratoxin A in Cannabis and Cannabis Products by LC-Fluorescence Detection Using Cleanup with Either Multiantibody Immunoaffinity Columns or an Automated System with In-Line Reusable Immunoaffinity Cartridges.

BACKGROUND: Evidence of fungal contamination of cannabis plants during drying has raised concerns of potential mycotoxin contamination of leaves and flowers and subsequent contamination of derived edible cannabis products. Methods are, therefore, needed for routine monitoring of cannabis to ensure consumer safety consistent with long-standing controls for mycotoxins such as aflatoxins and ochratoxin A (OTA) in foodstuffs. OBJECTIVE: To generate preliminary validation data to demonstrate fitness-for-purpose of methods for aflatoxins and OTA in cannabis and cannabis products. METHODS: Extraction of solid matrices with acetonitrile-water (75 + 25) and direct analysis of energy drinks after dilution. Extracts were either passed manually though an immunoaffinity column (IAC) containing antibodies to both aflatoxins and OTA or were analyzed sequentially using an automated system with in-line reusable immunoaffinity cartridges for aflatoxins or OTA. In both cases, analysis was by LC with fluorescence detection. RESULTS: Recoveries were in the range of 76-120% with relative SDs from 0.8 to 6.6% for aflatoxins and OTA spiked into cannabis dried leaves and flowers, hemp tea, oils, capsules, cookies, chocolate brownies, and an energy drink. CONCLUSIONS: The methods described in this paper are suitable for the cleanup of sample extracts of cannabis and cannabis products. HIGHLIGHTS: Manual and automated methods with IAC cleanup have been shown to be suitable for routine control of aflatoxins and OTA in cannabis and cannabis products.

Collecting data on violence against children and young people: need for a universal standard.

Preventing and responding to violence against children is an aim of the new Sustainable Development Goals. Numerous agencies are now collecting data from children about violence, including academics, non-governmental organisations, government agencies, consultants and others. Data are necessary to ensure appropriate prevention and response, but there is a real risk of harm to children if ethical standards are not adhered to. There are additional complexities in settings where child protection systems are not well developed. We propose specific suggestions for good practice, based on our past experience and policies, and call for all agencies to adhere to high ethical standards.