The development of the Belgian paediatric clinical trial network.

Paediatric clinical trials are critical to ensure that medications prescribed to children are safe and effective. However, evidence-based dosing and labelling of such medications remain limited, and most clinical trials in paediatrics fail. Factors for lack of trial completion include performance at site level (limited patient recruitment, limited site staff experience and lack of infrastructure), the sponsor team (limited paediatric specific expertise in design, uncertainties on robustness of biomarkers or outcome variables) as well as regulatory and administrative burdens. As a result of the growing demand for site support, the Belgian Paediatric Clinical Research Network (BPCRN) established in 2009 has been relaunched in 2018 to improve paediatric clinical trials, with the support of innovative-medicines-initiative 2 (IMI2) pan-European network conect4children (c4c) and the transatlantic network I-ACT for Children (US).This paper highlights the formation of the BPCRN and the practical insights it offers for advancing paediatric clinical trials through national networks. A national network can improve trial quality, safety and efficiency, provide clinical research expertise, identify suitable sites, and help with troubleshooting of common trial issues. The BPCRN's centralized approach has advanced paediatric clinical trials by streamlining communication and standardizing trial conduct. Challenges and opportunities have arisen, including a relaunch in 2018, orphan medicine trials, and network sustainability. Collaboration between network activities, government support, site-level improvements, efficient communication, and interaction with industry are key to achieve lasting transformation in paediatric medicine research.

The impact of cancer and chemotherapy during pregnancy on child neurodevelopment: A multimodal neuroimaging analysis.

BACKGROUND: This study applies multimodal MRI to investigate neurodevelopment in nine-year-old children born to cancer-complicated pregnancies. METHODS: In this cohort study, children born after cancer-complicated pregnancies were recruited alongside 1:1 matched controls regarding age, sex and gestational age at birth (GA). Multimodal MRI was used to investigate whole-brain and subcortical volume, cortical structure (using surface-based morphometry), white matter microstructure (using fixel-based analysis) and functional connectivity (using resting-state blood-oxygen-level-dependant signal correlations). Graph theory probed whole-brain structural and functional organization. For each imaging outcome we conducted two group comparisons: 1) children born after cancer-complicated pregnancies versus matched controls, and 2) the subgroup of children with prenatal chemotherapy exposure versus matched controls. In both models, we used the covariate of GA and the group-by-GA interaction, using false-discovery-rate (FDR) or family-wise-error (FWE) correction for multiple comparisons. Exploratory post-hoc analyses investigated the relation between brain structure/function, neuropsychological outcome and maternal oncological/obstetrical history. FINDINGS: Forty-two children born after cancer-complicated pregnancies were included in this study, with 30 prenatally exposed to chemotherapy. Brain organization and functional connectivity were not significantly different between groups. Both cancer and chemotherapy in pregnancy, as compared to matched controls, were associated with a lower travel depth, indicating less pronounced gyrification, in the left superior temporal gyrus (pFDR ≤ 006), with post-hoc analysis indicating platinum derivatives during pregnancy as a potential risk factor (p = .028). Both cancer and chemotherapy in pregnancy were related to a lower fibre cross-section (FCS) and lower fibre density and cross-section (FDC) in the posterior corpus callosum and its tapetal fibres, compared to controls. Higher FDC in the chemotherapy subgroup and higher FCS in the whole study group were observed in the anterior thalamic radiations. None of the psycho-behavioural parameters correlated significantly with any of the brain differences in the study group or chemotherapy subgroup. INTERPRETATION: Prenatal exposure to maternal cancer and its treatment might affect local grey and white matter structure, but not functional connectivity or global organization. While platinum-based therapy was identified as a potential risk factor, this was not the case for chemotherapy in general. FUNDING: This project has received funding from the European Union's Horizon 2020 research and innovation program (European Research council, grant no 647,047), the Foundation against cancer (Stichting tegen kanker, grant no. 2014-152) and the Research Foundation Flanders (FWO, grants no. 11B9919N, 12ZV420N).

226Ra, 222Rn AND PERMEABILITY OF BELGIAN SOILS IN RELATION WITH INDOOR RADON RISK.

Knowing the concentration of 226Ra in soil and of 222Rn in soil gas is important for the analysis of indoor radon data and the prediction of radon-prone areas. Except for soil Rn in Ardenne, the data concerning these two radionuclides in Belgian soils are very scarce. In the context of Master theses and international courses, students made 92 measurements of 226Ra in soil samples, 105 of 222Rn in soil gas, and 74 of soil permeability, a significant addition to the existing similar data. The data are analysed in relation with soil texture, geological units and indoor radon risk. There is no clear correlation between radium in soil and indoor radon risk, the most important factor of risk being soil permeability.

Indoor radon in the region of Brussels.

The indoor radon (222Rn) concentration has been measured by charcoal detectors in 278 buildings in the region of Brussels, Belgium. The correlation with the nature of the subsoil can be studied in detail thanks to the available geotechnical map. With a geometrical mean indoor radon concentration of 19 Bq m(-3), Brussels can be considered as generally unaffected by the radon problem. No value higher than 400 Bq m(-3) (the EU reference level for existing houses) was measured in an occupied room. However, two factors that may enhance the risk are identified: the absence of a basement or a ventilated crawl space, and the presence of loess, under the house. About one third of the houses without basements or ventilated crawl spaces built on loess show an indoor radon concentration above 200 Bq m(-3) (the EU reference level for new houses).

Perceptual effects of scene context on object identification.

In a number of studies the context provided by a real-world scene has been claimed to have a mandatory, perceptual effect on the identification of individual objects in such a scene. This claim has provided a basis for challenging widely accepted data-driven models of visual perception in order to advocate alternative models with an outspoken top-down character. The present paper offers a review of the evidence to demonstrate that the observed scene-context effects may be the product of post-perceptual and task-dependent guessing strategies. A new research paradigm providing an on-line measure of genuine perceptual effects of context on object identification is proposed. First-fixation durations for objects incidentally fixated during the free exploration of real-world scenes are shown to increase when the objects are improbable in the scene or violate certain aspects of their typical spatial appearance in it. These effects of contextual violations are shown to emerge only at later stages of scene exploration, contrary to the notion of schema-driven scene perception effective from the very first scene fixation. In addition, evidence is reported in support of the existence of a facilitatory component in scene-context effects. This is taken to indicate that the context directly affects the ease of perceptual object processing and does not merely serve as a framework for checking the plausibility of the output of perceptual processes. Finally, our findings are situated against other contrasting results. Some future research questions are high-lighted.