Current Guidelines on Fat Intake in Pregnant and Lactating Women, Infants, Children, and Adolescents: A Scoping Review.

INTRODUCTION: Dietary fat intake in pregnancy, lactation, and childhood determines child growth, neurodevelopment, and long-term health. METHODS: We performed a scoping review of dietary guidelines on fat intake for pregnant and lactating women, infants, children, and adolescents. We systematically searched several databases and websites for relevant documents published in English from 2015 to 2019. RESULTS: We included 14 documents. Of those, eight targeted pregnant and/or lactating women, mainly recommending daily intake of approx. 250 mg/d of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), while one advised supplementing 800 mg/d DHA and 100 mg/d EPA in women of low omega-3 fatty acid status. The number of guidelines for infants was low (n = 3). Recommended intakes of total fat were 30-40% and 20-35% of total energy intake (TEI) for infants and children, respectively. Intakes of saturated fatty acids (SFAs) <10% of TEI and avoidance of trans-fatty acids (TFAs) were recommended across childhood. The methodology applied to develop guidelines and to grade the strength of recommendations was heterogeneous. CONCLUSION: Quantitative recommendations on fat intake during pregnancy focused mainly on PUFA intake, and those targeting infants were limited. Consistent recommendations were provided for total fat, SFA, and TFA intake in childhood; however, strength of recommendation was mostly not reported.

Evidence from clinical trials on high-risk medical devices in children: a scoping review.

BACKGROUND: Meeting increased regulatory requirements for clinical evaluation of medical devices marketed in Europe in accordance with the Medical Device Regulation (EU 2017/745) is challenging, particularly for high-risk devices used in children. METHODS: Within the CORE-MD project, we performed a scoping review on evidence from clinical trials investigating high-risk paediatric medical devices used in paediatric cardiology, diabetology, orthopaedics and surgery, in patients aged 0-21 years. We searched Medline and Embase from 1st January 2017 to 9th November 2022. RESULTS: From 1692 records screened, 99 trials were included. Most were multicentre studies performed in North America and Europe that mainly had evaluated medical devices from the specialty of diabetology. Most had enrolled adolescents and 39% of trials included both children and adults. Randomized controlled trials accounted for 38% of the sample. Other frequently used designs were before-after studies (21%) and crossover trials (20%). Included trials were mainly small, with a sample size <100 participants in 64% of the studies. Most frequently assessed outcomes were efficacy and effectiveness as well as safety. CONCLUSION: Within the assessed sample, clinical trials on high-risk medical devices in children were of various designs, often lacked a concurrent control group, and recruited few infants and young children. IMPACT: In the assessed sample, clinical trials on high-risk medical devices in children were mainly small, with variable study designs (often without concurrent control), and they mostly enrolled adolescents. We provide a systematic summary of methodologies applied in clinical trials of medical devices in the paediatric population, reflecting obstacles in this research area that make it challenging to conduct adequately powered randomized controlled trials. In view of changing European regulations and related concerns about shortages of high-risk medical devices for children, our findings may assist competent authorities in setting realistic requirements for the evidence level to support device conformity certification.

Fat Intake and Fat Quality in Pregnant and Lactating Women, Infants, Children, and Adolescents and Related Health Outcomes: A Scoping Review of Systematic Reviews of Prospective Studies.

INTRODUCTION: Dietary fat intake during pregnancy and childhood is important for health. However, several health aspects are inconclusive. METHODS: We systematically searched Medline, Cochrane Library, and Epistemonikos for systematic reviews (SRs) of randomized controlled trials (RCTs) and/or prospective cohort studies published from January 01, 2015, to December 31, 2019, assessing the association of dietary fat intake (including dietary supplements) during pregnancy and across childhood with pregnancy, perinatal, and child health outcomes. RESULTS: Thirty-one SRs, mainly of RCTs, were included. Omega-3 fatty acids supplementation during pregnancy reduced the risk of early preterm birth, and in some SRs also any preterm birth, increased gestation length and birth weight, but mostly was not associated with other pregnancy/perinatal outcomes. Pre- and postnatal polyunsaturated fatty acids (PUFAs) intake was not consistently associated with growth, neurological, visual and cognitive outcomes, allergic diseases, cardiovascular, and metabolic health in childhood. Reduced saturated fatty acids (SFAs) intake and its replacement with PUFA/monounsaturated fatty acids had favourable effects on blood pressure and blood lipids in children. No apparent effects of total or trans fat on health outcomes across target groups were observed. CONCLUSION: Omega-3 PUFA supplementation during pregnancy and SFA intake reduction in childhood require further consideration in dietary recommendations targeting these populations.

European expert recommendations on clinical investigation and evaluation of high-risk medical devices for children.

Several high-risk medical devices for children have become unavailable in the European Union (EU), since requirements and costs for device certification increased markedly due to the EU Medical Device Regulation. The EU-funded CORE-MD project held a workshop in January 2023 with experts from various child health specialties, representatives of European paediatric associations, a regulatory authority and the European Commission Directorate General Health and Food Safety. A virtual follow-up meeting took place in March 2023. We developed recommendations for investigation of high-risk medical devices for children building on participants' expertise and results of a scoping review of clinical trials on high-risk medical devices in children. Approaches for evaluating and certifying high-risk medical devices for market introduction are proposed.

Control of Spin Helix Symmetry in Semiconductor Quantum Wells by Crystal Orientation.

We investigate the possibility of spin-preserving symmetries due to the interplay of Rashba and Dresselhaus spin-orbit coupling in n-doped zinc-blende semiconductor quantum wells of general crystal orientation. It is shown that a conserved spin operator can be realized if and only if at least two growth direction Miller indices agree in modulus. The according spin-orbit field has in general both in-plane and out-of-plane components and is always perpendicular to the shift vector of the corresponding persistent spin helix. We also analyze higher-order effects arising from the Dresselhaus term, and the impact of our results on weak (anti)localization corrections.