Presentations of children to emergency departments across Europe and the COVID-19 pandemic: A multinational observational study

During the initial phase of the Coronavirus Disease 2019 (COVID-19) pandemic, reduced numbers of acutely ill or injured children presented to emergency departments (EDs). Concerns were raised about the potential for delayed and more severe presentations and an increase in diagnoses such as diabetic ketoacidosis and mental health issues. This multinational observational study aimed to study the number of children presenting to EDs across Europe during the early COVID-19 pandemic and factors influencing this and to investigate changes in severity of illness and diagnoses. Routine health data were extracted retrospectively from electronic patient records of children aged 18 years and under, presenting to 38 EDs in 16 European countries for the period January 2018 to May 2020, using predefined and standardized data domains. Observed and predicted numbers of ED attendances were calculated for the period February 2020 to May 2020. Poisson models and incidence rate ratios (IRRs), using predicted counts for each site as offset to adjust for case-mix differences, were used to compare age groups, diagnoses, and outcomes. Reductions in pediatric ED attendances, hospital admissions, and high triage urgencies were seen in all participating sites. ED attendances were relatively higher in countries with lower SARS-CoV-2 prevalence (IRR 2·26, 95% CI 1·90 to 2·70, p < 0.001) and in children aged <12 months (12 to <24 months IRR 0·86, 95% CI 0·84 to 0·89; 2 to <5 years IRR 0·80, 95% CI 0·78 to 0·82; 5 to <12 years IRR 0·68, 95% CI 0·67 to 0·70; 12 to 18 years IRR 0·72, 95% CI 0·70 to 0·74; versus age <12 months as reference group, p < 0.001). The lowering of pediatric intensive care admissions was not as great as that of general admissions (IRR 1·30, 95% CI 1·16 to 1·45, p < 0.001). Lower triage urgencies were reduced more than higher triage urgencies (urgent triage IRR 1·10, 95% CI 1·08 to 1·12; emergent and very urgent triage IRR 1·53, 95% CI 1·49 to 1·57; versus nonurgent triage category, p < 0.001). Reductions were highest and sustained throughout the study period for children with communicable infectious diseases. The main limitation was the retrospective nature of the study, using routine clinical data from a wide range of European hospitals and health systems. Reductions in ED attendances were seen across Europe during the first COVID-19 lockdown period. More severely ill children continued to attend hospital more frequently compared to those with minor injuries and illnesses, although absolute numbers fell. ISRCTN91495258 https://www.isrctn.com/ISRCTN91495258

Arthrites de l'enfant (étude rétrospective descriptive chez les enfants hospitalisés à l' Hôpital Robert Debré, sur une période de 2 ans)

Chez l'enfant, les causes des arthrites sont variées : septique, virale, réactionnelle, arthrite juvénile idiopathique (AJI).Les objectifs sont de décrire les enfants hospitalisés pour un premier épisode d'arthrite à l' hôpital Robert Debré en 2008 et 2009 et de comparer les caractéristiques des enfants ayant nécessité une ponction articulaire. Les caractéristiques sont comparées par des tests non paramétriques. Le délai avant obtention d'une CRP négative est décrit par méthode de Kaplan-Meier. 173 enfants ont été hospitalisés pour arthrite entre 2008 et 2009. la première cause est l' arthrite septique ( 43,4 % des cas), dont 69,3 % sont dues à Kingella Kingae. Les AJI représentent 8,1 % des cas et les arthrites sans diagnostic de certitude 40,4% des cas . Les arthrites septiques surviennent à un âge plus jeune (1,5 ans [ 1er quartile-3ème quartile : 1.2-3.0 ]) que les AJI (3.6 ans [2.2-5.6]). Elles sont associées à une durée plus courte des symptômes ( 2 jours vs. 7 jours), à une atteinte de type mono-articulaire, à une numération plaquettaire plus faible (346x109/L [284-421] vs. 460 [364-522]) et à une cellularité plus élevée du liquide articulaire (147 éléments xl03/mm3 [71-227] vs. 51 [12-113]) comparativement aux AJI. Le délai avant apyrexie est plus long dans les AJI que dans les arthrites septiques (8.1 jours vs. 1.2 jours; p=0.02), de même que le délai avant obtention d'une CRP négative (18% de réussite à 7 jours [IC95: 51.7-72.5] vs. 82% [6.3-29.6] pour les arthrites septiques, p=0.01 )PARIS6-Bibl.Pitié-Salpêtrie (751132101) / SudocSudocFranceF

Full versus half dose of antenatal betamethasone to prevent severe neonatal respiratory distress syndrome associated with preterm birth: study protocol for a randomised, multicenter, double blind, placebo-controlled, non-inferiority trial (BETADOSE)

International audienceBACKGROUND: Although antenatal betamethasone is recommended worldwide for women at risk of preterm delivery, concerns persist regarding the long-term effects associated with this treatment. Indeed, adverse events, mainly dose-related, have been reported. The current recommended dose of antenatal betamethasone directly derives from sheep experiments performed in the late 60's and has not been challenged in 45 years. Therefore, randomized trials evaluating novel dose regimens are urgently needed.METHODS: A randomised, double blind, placebo-controlled, non-inferiority trial will be performed in 37 French level 3 maternity units. Women with a singleton pregnancy at risk of preterm delivery before 32 weeks of gestation having already received a first 11.4 mg injection of betamethasone will be randomised to receive either a second injection of 11.4 mg betamethasone (full dose arm) or placebo (half dose arm) administered intramuscularly 24 h after the first injection. The primary binary outcome will be the occurrence of severe respiratory distress syndrome (RDS), defined as the need for exogenous intra-tracheal surfactant in the first 48 h of life. Considering that 20% of the pregnant women receiving the full dose regimen would have a neonate with severe RDS, 1571 patients in each treatment group are required to show that the half dose regimen is not inferior to the full dose, that is the difference in severe RDS rate do not exceed 4% (corresponding to a Relative Risk of 20%), with a 1-sided 2.5% type-1 error and a 80% power. Interim analyses will be done after every 300 neonates who reach the primary outcome on the basis of intention-to-treat, using a group-sequential non-inferiority design.DISCUSSION: If the 50% reduced antenatal betamethasone dose is shown to be non-inferior to the full dose to prevent severe RDS associated with preterm birth, then it should be used consistently in women at risk of preterm delivery and would be of great importance to their children

A Bayesian non-inferiority approach using experts' margin elicitation - application to the monitoring of safety events

When conducing Phase-III trial, regulatory agencies and investigators might want to get reliable information about rare but serious safety outcomes during the trial. Bayesian non-inferiority approaches have been developed, but commonly utilize historical placebo-controlled data to define the margin, depend on a single final analysis, and no recommendation is provided to define the prespecified decision threshold. In this study, we propose a non-inferiority Bayesian approach for sequential monitoring of rare dichotomous safety events incorporating experts' opinions on margins

Exploring how non-inferiority and equivalence are assessed in paediatrics: a systematic review

International audienc

Gas exchanges in children with cystic fibrosis or primary ciliary dyskinesia: A retrospective study

International audiencePrimary ciliary dyskinesia (PCD) and cystic fibrosis (CF) both entail bronchiectasis and pulmonary impairment as measured using spirometry, during childhood. We aimed at looking whether blood gas exchanges progressed differently between CF and PCD children in a retrospective study of repeated measurements. Comparisons between groups (Wilcoxon-Mann-Whitney and Chi-squared tests) and a mixed linear model, adjusted for age, evaluated associations between diseases and PaO2, PaCO2, or PaO2-PaCO2 ratio.Among 42 PCD and 73 CF children, 62% and 59% had respectively bronchiectasis (P = 0.75). Spirometry and blood gases were similar at inclusion (PaO2 median [IQR] PCD −1.80 [−3.40; −0.40]; CF −1.80 [−4.20; 0.60] z-scores; P = 0.72). PaO2 and PaO2-PaCO2 ratio similarly and significantly decreased with age in both groups (P < 0.01) whereas PaCO2 increased more in CF (P = 0.02) remaining within the range of normal (except for one child).To conclude, gas exchange characteristics, similarly initially impaired in PCD and CF children, tended to less deteriorate with time in PCD children who could benefit from an early diagnosis

Severity of acute gastroenteritis in infants infected by G1 or G9 rotaviruses.

International audienceBACKGROUND: Group A rotaviruses are the main viral causative agent of acute diarrhea, and cause considerable morbidity in children. G9 rotaviruses have recently emerged all over the world and are thought to give more severe symptoms because of a lack of previous exposure and the absence of maternal antibodies in patients. OBJECTIVES: To determine the clinical severity of G9 infections compared to G1 infections in hospitalized children. STUDY DESIGN: The prospective study was conducted from 2004 to 2007 in French children under 5 years old hospitalized for acute gastroenteritis. The rotaviruses were detected in stools by ELISA tests and genotyped by RT-PCR on the basis of their outer capsid proteins. The duration of hospitalization, the Vesikari clinical score, and the requirement for intravenous rehydration were compared. RESULTS: The stools from 370 children were analyzed and 162 stools infected by G1 (n=76) or G9 (n=86) rotaviruses were analyzed. Age and gender distribution were similar in the two groups as was the mean duration of hospitalization (2.7 days). The Vesikari scores were 12.96 and 12.83 in G1P[8] and G9P[8] groups (p=0.417), respectively, in which 55.3 and 53.5% of the children, respectively, were rehydrated with an intravenous line. CONCLUSIONS: No difference in severity was found between G1 and G9 rotavirus infections. Rigorous surveillance to monitor changes in the ecology of rotavirus infections is necessary, as emerging strains are more likely to cause severe gastroenteritis and not respond to current rotavirus vaccines

Professional’s Perspectives on Care Management of Young People with Perinatally Acquired HIV during Transition: A Qualitative Study in Adult Care Setting

<div><p>Background</p><p>Increasing numbers of young people with perinatally acquired HIV are surviving to adulthood. When they come of age, they leave pediatric services in which they were followed and have to be transferred to the adult health care system. Difficulties in adaptation to adult care and the numbers of young people lost to follow up after transfer to adult care have been reported. This transition phase and their retention in adult care are crucial in maintaining the clinical status of these young with HIV in adulthood. Our study aimed to explore how HIV professionals working in adult care perceive and adapt their practices to young people in transition.</p><p>Methods</p><p>Qualitative interviews were conducted with 18 health and social services professionals in hospitals or patient associations in France. A thematic analysis was conducted.</p><p>Results</p><p>Adult care professionals were found to be making a distinction between these young people and their patients who were infected during adulthood. On the basis of the healthcare teams’ experience, a simplified categorization of these young people into four levels can be used: those “who have everything good”; those who have some deficiencies that must be addressed; those “who have everything bad”; and those lost to follow up. Professionals interviewed highlighted the difficulties they encountered with young people in transition. Three types of problematic situations were identified: problems of acceptance of the disease; communication problems; and problems of disorientation in the new care environment.</p><p>Conclusions</p><p>Despite the lack of specific training or national policy recommendations for the integration of young people with perinatally acquired HIV into adult services, all the adult healthcare teams interviewed tried to adapt their practice to this population. The results suggested that professional involvement during transition should depend on the characteristics of the patient, not be limited to a single transition model and that a dedicated structure for transition care is not appropriate for all young people.</p></div

Acute monoarthritis in young children: comparing the characteristics of patients with juvenile idiopathic arthritis versus septic and undifferentiated arthritis

International audienceAcute arthritis is a common cause of consultation in pediatric emergency wards. Arthritis can be caused by juvenile idiopathic arthritis (JIA), septic (SA) or remain undetermined (UA). In young children, SA is mainly caused by Kingella kingae (KK), a hard to grow bacteria leading generally to a mild clinical and biological form of SA. An early accurate diagnosis between KK-SA and early-onset JIA is essential to provide appropriate treatment and follow-up. The aim of this work was to compare clinical and biological characteristics, length of hospital stays, duration of intravenous (IV) antibiotics exposure and use of invasive surgical management of patients under 6 years of age hospitalized for acute monoarthritis with a final diagnosis of JIA, SA or UA. We retrospectively analyzed data from < 6-year-old children, hospitalized at a French tertiary center for acute mono-arthritis, who underwent a joint aspiration. Non-parametric tests were performed to compare children with JIA, SA or UA. Bonferroni correction for multiple comparisons was applied with threshold for significance at 0.025. Among the 196 included patients, 110 (56.1%) had SA, 20 (10.2%) had JIA and 66 (33.7%) had UA. Patients with JIA were older when compared to SA (2.7 years [1.8-3.6] versus 1.4 [1.1-2.1], p < 0.001). Presence of fever was not different between JIA and SA or UA. White blood cells in serum were lower in JIA (11.2 × 109/L [10-13.6]) when compared to SA (13.2 × 109/L [11-16.6]), p = 0.01. In synovial fluid leucocytes were higher in SA 105.5 × 103 cells/mm3 [46-211] compared to JIA and UA (42 × 103 cells/mm3 [6.4-59.2] and 7.29 × 103 cells/mm3 [2.1-72] respectively), p < 0.001. Intravenous antibiotics were administered to 95% of children with JIA, 100% of patients with SA, and 95.4% of UA. Arthrotomy-lavage was performed in 66.7% of patients with JIA, 79.6% of patients with SA, and 71.1% of patients with UA. In children less than 6 years of age with acute mono-arthritis, the clinical and biological parameters currently used do not reliably differentiate between JIA, AS and UA. JIA subgroups that present a diagnostic problem at the onset of monoarthritis before the age of 6 years, are oligoarticular JIA and systemic JIA with hip arthritis. The development of new biomarkers will be required to distinguish JIA and AS caused by Kingella kingae in these patients

Full versus half dose of antenatal betamethasone to prevent severe neonatal respiratory distress syndrome associated with preterm birth: study protocol for a randomised, multicenter, double blind, placebo-controlled, non-inferiority trial (BETADOSE)

Abstract Background Although antenatal betamethasone is recommended worldwide for women at risk of preterm delivery, concerns persist regarding the long-term effects associated with this treatment. Indeed, adverse events, mainly dose-related, have been reported. The current recommended dose of antenatal betamethasone directly derives from sheep experiments performed in the late 60’s and has not been challenged in 45 years. Therefore, randomized trials evaluating novel dose regimens are urgently needed. Methods A randomised, double blind, placebo-controlled, non-inferiority trial will be performed in 37 French level 3 maternity units. Women with a singleton pregnancy at risk of preterm delivery before 32 weeks of gestation having already received a first 11.4 mg injection of betamethasone will be randomised to receive either a second injection of 11.4 mg betamethasone (full dose arm) or placebo (half dose arm) administered intramuscularly 24 h after the first injection. The primary binary outcome will be the occurrence of severe respiratory distress syndrome (RDS), defined as the need for exogenous intra-tracheal surfactant in the first 48 h of life. Considering that 20% of the pregnant women receiving the full dose regimen would have a neonate with severe RDS, 1571 patients in each treatment group are required to show that the half dose regimen is not inferior to the full dose, that is the difference in severe RDS rate do not exceed 4% (corresponding to a Relative Risk of 20%), with a 1-sided 2.5% type-1 error and a 80% power. Interim analyses will be done after every 300 neonates who reach the primary outcome on the basis of intention-to-treat, using a group-sequential non-inferiority design. Discussion If the 50% reduced antenatal betamethasone dose is shown to be non-inferior to the full dose to prevent severe RDS associated with preterm birth, then it should be used consistently in women at risk of preterm delivery and would be of great importance to their children. Trial registration ClinicalTrials.gov identifier: NCT 02897076 (registration date 09/13/2016)