Background: Human milk analyzers are increasingly used to rapidly measure the macronutrient content in breast milk for individual target fortification, to reduce the risk of postnatal growth restriction. However, many milk analyzers are used without calibration, validation or quality assurance. Aims: To investigate measurement quality between different human milk analyzers, to test whether accuracy and precision of devices can be improved by establishing individual calibration curves, and to assess long-term stability of measurements, following good clinical laboratory practice (GCLP). Methods: Sets of identical breast milk samples were sent to 13 participating centres in North America and Europe, for a total of 15 devices. The study included 3 sets of samples: A) initial assessment of the device's performance consisting of 10 calibration samples with random replicates; B) long term stability and quality control consisting of 2 batches of samples to be measured every time before the device is used, over 6 months; C) ring trial consisting of 2 samples to be measured monthly. The devices tested were Unity SpectraStar (n ¼ 5) and MIRIS Human Milk Analyzer (n ¼ 10). Results: There are significant variations in accuracy and precision between different milk analyzers' fat, protein and lactose measurements. However, the accuracy of measurements can be improved by establishing individual correction algorithms. Repeated measurements are more robust when coming from a larger batch volume. Long term stability also varies between devices.
Conclusion:The variations in measurements between devices are clinically significant and would impact both daily dietary prescriptions, and the outcomes of clinical studies assessing the effect of targeted adjustment of nutrient intake in preterm babies. This study shows that it is crucial to follow GCLP when using milk analyzers to ensure proper measurement of macronutrients, similar to what is required of other medical devices.
Loneliness and social isolation have negative consequences on physical and mental health in both adult and pediatric populations. Children with neurodevelopmental disabilities (NDD) are often excluded and experience more loneliness than their typically developing peers. This scoping review aims to identify the type of studies conducted in children with NDD to determine the effects of loneliness and/or social isolation. Three electronic databases (Ovid MEDLINE, EMBASE, PsychINFO) were searched from inception until 5 February 2019. Two independent reviewers screened the citations for inclusion and extracted data from the included articles. Quantitative (i.e., frequency analysis) and qualitative analyses (i.e., content analysis) were completed. From our search, 5768 citations were screened, 29 were read in full, and 12 were included. Ten were case-control comparisons with cross-sectional assessment of various outcomes, which limited inference. Autism spectrum disorder, attention-deficit/hyperactivity disorder, and learning disorder were the most commonly studied NDD. This review showed that loneliness among children with NDD was associated with negative consequences on mental health, behaviour, and psychosocial/emotional development, with a likely long-term impact in adulthood. Lack of research in this area suggests that loneliness is not yet considered a problem in children with NDD. More studies are warranted using prospective designs and a larger sample size with a focus on the dynamic aspect of loneliness development.
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