Background The COVID-19 pandemic has had a devastating impact on multiple aspects of healthcare, but has also triggered new ways of working, stimulated novel approaches in clinical research and reinforced the value of previous innovations. Conect4children (c4c, www.conect4children.org) is a large collaborative European network to facilitate the development of new medicines for paediatric populations, and is made up of 35 academic and 10 industry partners from 20 European countries, more than 50 third parties, and around 500 affiliated partners. Methods We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equity. Findings We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equityWe provide examples of research innovation, and follow this with recommendations to improve the efficiency of future trials, drawing on industry perspectives, regulatory considerations, infrastructure requirements and parent–patient–public involvement. We end with a comment on progress made towards greater international harmonisation of paediatric research and how lessons learned from COVID-19 studies might assist in further improvements in this important area.

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This report describes an outbreak of bronchitis and bronchopneumonia among young dogs in a breeding kennel following the introduction of two pups from another area. Bordetella bronchiseptica was isolated in heavy culture from affected animals which responded well to antibacterial therapy. There was no evidence of distemper virus involvement. Important bacteriological properties of Bord. bronchiseptica are discussed particularly as they relate to its known pathogenicity in the young of several species of animal. During the outbreak reported, it was noted that only young pups were clinically affected and it is suggested that Bord. bronchiseptica may be pathogenic in a certain age-group within the canine population. This seems to require further investigation.

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*presenting author, supported by ERAWEB II scholarship for postdoctoral program at the KU Leuven, Belgium (2014–2015)IntroductionVancomycin, a glycopeptide antibiotic, is frequently used for late onset sepsis (LOS) and catheter-related infection. Larger inter- and intra-patient variability, combined with a narrow therapeutic index, warrants therapeutic drug monitoring (TDM). However, large inter-individual variability in PK parameters in neonates is documented, only partly explained by covariates such as weight, age or serum creatinine (1,2). In the current study, we focus on the potential impact of between assay differences for vancomycin (3) on the variability in its concentration in a single neonatal intensive care unit (NICU).MethodsVancomycin TDM observations of neonates and young infants treated with intravenous vancomycin, mainly for (suspected) LOS (ie, >72 hours after birth), in the Leuven NICU, Belgium, between June 2011 and December 2014. Our patient population, consists of (pre)term neonates, inborn or transferred, in need of specialized care related to prematurity, infections, perinatal asphyxia, congenital diseases (eg, surgery for cardiopathy, congenital diaphragmatic hernia, or esophageal atresia), or other diseases. Clinical characteristics at birth, as well as characteristics at the moment of TDM were extracted from the patient files. We aimed to document early vancomycin exposure, therefore only first trough levels were included. Serum vancomycin assay was performed either with a particle-enhanced turbidimetric inhibitionimmunoassay method (Siemens Dimension; Dade Behring, Deerfield, Illinois–PETINIA) or with an enzyme multiplied immunoassay technique (Cobas c702; Roche Diagnostics, Basel, Germany–COBAS). The data were analyzed by Chi-square test, t test and Mann-Whitney U test. Linear Mix Model was used to assess significant differences between groups, when adjusting for confounding factors. Data were analyzed in SPSS 20.0 (IBM corp.), p-value <0.05 was significant.ResultsIn total, 564 vancomycin TDM observations, 311 assayed with PETINIA and 253 with COBAS, were included. Both cohorts had comparable clinical characteristics (median [min-max] current weight 2150 [420–5000] grams for PETINIA vs. 2120 [500–5840] grams for COBAS, and median postmenstrual age 35 [25–58] weeks for PETINIA vs. 35 [25–51] weeks for COBAS). We determined the significant difference between the vancomycin concentrations using two different immunoassays: PETINIA vs. COBAS (F=17.971; p<0.001). When adjusting for current body weight and postmenstrual age, the major covariates associated with vancomycin serum trough levels in neonates, the difference in vancomycin concentration between cohorts was statistically significant (F=17.076, p<0.001, F=18.951, p<0.001, respectively). Overall, immunoassays PETINIA and COBAS significantly differed by vancomycin concentrations when adjusting for covariates, and the mean difference for vancomycin concentration was 2.167 mg/l.ConclusionThe present study confirms the impact of assays on t...