Extremely Preterm Infant Admissions Within the SafeBoosC-III Consortium During the COVID-19 Lockdown

Objective: To evaluate if the number of admitted extremely preterm (EP) infants (born before 28 weeks of gestational age) differed in the neonatal intensive care units (NICUs) of the SafeBoosC-III consortium during the global lockdown when compared to the corresponding time period in 2019. Design: This is a retrospective, observational study. Forty-six out of 79 NICUs (58%) from 17 countries participated. Principal investigators were asked to report the following information: (1) Total number of EP infant admissions to their NICU in the 3 months where the lockdown restrictions were most rigorous during the first phase of the COVID-19 pandemic, (2) Similar EP infant admissions in the corresponding 3 months of 2019, (3) the level of local restrictions during the lockdown period, and (4) the local impact of the COVID-19 lockdown on the everyday life of a pregnant woman. Results: The number of EP infant admissions during the first wave of the COVID-19 pandemic was 428 compared to 457 in the corresponding 3 months in 2019 (−6.6%, 95% CI −18.2 to +7.1%, p = 0.33). There were no statistically significant differences within individual geographic regions and no significant association between the level of lockdown restrictions and difference in the number of EP infant admissions. A post-hoc analysis based on data from the 46 NICUs found a decrease of 10.3%in the total number of NICU admissions (n = 7,499 in 2020 vs. n = 8,362 in 2019). Conclusion: This ad hoc study did not confirm previous reports of a major reduction in the number of extremely pretermbirths during the first phase of the COVID-19 pandemic. Clinical Trial Registration: ClinicalTrial.gov, identifier: NCT04527601 (registered August 26, 2020), https://clinicaltrials.gov/ct2/show/NCT04527601

Hemodynamic effects of fluid restriction in preterm infants with significant patent ductus arteriosus

Objective: To determine the hemodynamic impact of fluid restriction in preterm newborns with significant patent ductus arteriosus. Study design: Newborns ≥24 and <32 weeks' gestational age with significant patent ductus arteriosus were eligible for this prospective multicenter observational study. We recorded hemodynamic and Doppler echocardiographic variables before and 24 hours after fluid restriction. Results: Eighteen newborns were included (gestational age 24.8 ± 1.1 weeks, birth weight 850 ± 180 g). Fluid intake was decreased from 145 ± 15 to 108 ± 10 mL/kg/d. Respiratory variables, fraction of inspired oxygen, blood gas values, ductus arteriosus diameter, blood flow-velocities in ductus arteriosus, in the left pulmonary artery and in the ascending aorta, and the left atrial/aortic root ratio were unchanged after fluid restriction. Although systemic blood pressure did not change, blood flow in the superior vena cava decreased from 105 ± 40 to 61 ± 25 mL/kg/min (P < .001). The mean blood flow-velocity in the superior mesenteric artery was lower 24 hours after starting fluid restriction. Conclusions: Our results do not support the hypothesis that fluid restriction has beneficial effects on pulmonary or systemic hemodynamics in preterm newborns. © 2012 Mosby, Inc.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Ictère nucléaire dans un contexte de naissance à domicile

This is the clinical history of a term baby born at home who presents a severe hyperbilirubinémia. The medical monitoring was assessed by a private midwife according to parental choice. On the third day of life, the newborn presented an icterus and was exposed to natural daylight in the familial greenhouse under the midwife recommandations. On that day, no laboratory test precised the bilirubin level. On the fifth day, a blood sampling revealed a very high blood bilirubinémia (31 mg/dl or 527 mmol/L), the baby is refered to our NICU and underwent an exchange transfusion. The radiological assessment report structural abnomalies in basal ganglia seen on both MRI and transfontannellar echography. These lesions are known to be responsible of cerebral palsy and hearing loos. The neurophysiologic investigations showed background abnormaly and depression. The extensive blood sampling excluded haemolysis. The clinical examination brought out neurologic impairement and weight loos in this exclusively breastfed baby. This clinical case point out the increasing risk of home Kernicterius as hospital stays diminish and homebirth enthousiasm rise up. The present clinical situation vouches for an adaptation of care giving to both mother and child at home in order to avoid this severe illness.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Metabolic fingerprinting reveals a novel candidate biomarker for prednisolone treatment in cattle

The use of glucocorticoids as growth promoters for meat-producing animals is strictly regulated within the European Union. However, in the past few years, a higher frequency of non-compliant bovine urine samples for prednisolone has been noticed, which could not be directly related to fraudulent use of prednisolone. As such, questions have risen about the origin of this compound. Unfortunately, at present, no decisive strategy has been established to discriminate between endogenous and exogenous prednisolone. In this study, an untargeted metabolomics strategy, based on Orbitrap and QqTOF mass spectrometry, was deployed to reveal urinary biomarkers, which are indicative for the exogenous administration of the synthetic glucocorticoid prednisolone. For this purpose, prednisolone was administered intramuscularly and per os to 12 bovines and a total of 2700 urine samples were collected before, during and after treatment. Multivariate statistical data analysis (i.e. OPLS-DA) revealed four differentiating metabolites that allowed discrimination between urine samples collected before and during prednisolone administration. None of these compounds were present in urine containing endogenous prednisolone, of which the formation was induced by the administration of a synthetic analogue of adrenocorticotropic hormone. Only one metabolite was retained as a highly suitable biomarker during growth-promoting and therapeutic prednisolone treatment, with 93.4 % sensitivity and 96.3 % specificity. Besides, this compound could be detected up to 4 days after a single therapeutic per os prednisolone administration. Based on accurate mass, isotope pattern, and MS/MS spectra, this compound was putatively annotated and is suggested as an actionable biomarker for exogenous prednisolone administration

Clinical, hormonal and imaging findings in 27 children with central diabetes insipidus

SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Additional file 2 of Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach

Additional file 2

Additional file 1 of Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach

Additional file 1

Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach

Abstract Background Data monitoring of clinical trials is a tool aimed at reducing the risks of random errors (e.g. clerical errors) and systematic errors, which include misinterpretation, misunderstandings, and fabrication. Traditional ‘good clinical practice data monitoring’ with on-site monitors increases trial costs and is time consuming for the local investigators. This paper aims to outline our approach of time-effective central data monitoring for the SafeBoosC-III multicentre randomised clinical trial and present the results from the first three central data monitoring meetings. Methods The present approach to central data monitoring was implemented for the SafeBoosC-III trial, a large, pragmatic, multicentre, randomised clinical trial evaluating the benefits and harms of treatment based on cerebral oxygenation monitoring in preterm infants during the first days of life versus monitoring and treatment as usual. We aimed to optimise completeness and quality and to minimise deviations, thereby limiting random and systematic errors. We designed an automated report which was blinded to group allocation, to ease the work of data monitoring. The central data monitoring group first reviewed the data using summary plots only, and thereafter included the results of the multivariate Mahalanobis distance of each centre from the common mean. The decisions of the group were manually added to the reports for dissemination, information, correcting errors, preventing furture errors and documentation. Results The first three central monitoring meetings identified 156 entries of interest, decided upon contacting the local investigators for 146 of these, which resulted in correction of 53 entries. Multiple systematic errors and protocol violations were identified, one of these included 103/818 randomised participants. Accordingly, the electronic participant record form (ePRF) was improved to reduce ambiguity. Discussion We present a methodology for central data monitoring to optimise quality control and quality development. The initial results included identification of random errors in data entries leading to correction of the ePRF, systematic protocol violations, and potential protocol adherence issues. Central data monitoring may optimise concurrent data completeness and may help timely detection of data deviations due to misunderstandings or fabricated data