Prophylactic corticosteroids for paediatric heart surgery with cardiopulmonary bypass.

BACKGROUND: Corticosteroids are routinely given to children undergoing cardiac surgery with cardiopulmonary bypass (CPB) in an attempt to ameliorate the inflammatory response. Their use is still controversial and the decision to administer the intervention can vary by centre and/or by individual doctors within that centre. OBJECTIVES: This review is designed to assess the benefits and harms of prophylactic corticosteroids in children between birth and 18 years of age undergoing cardiac surgery with CPB. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase and Conference Proceedings Citation Index-Science in June 2020. We also searched four clinical trials registers and conducted backward and forward citation searching of relevant articles. SELECTION CRITERIA: We included studies of prophylactic administration of corticosteroids, including single and multiple doses, and all types of corticosteroids administered via any route and at any time-point in the perioperative period. We excluded studies if steroids were administered therapeutically. We included individually randomised controlled trials (RCTs), with two or more groups (e.g. multi-drug or dose comparisons with a control group) but not 'head-to-head' trials without a placebo or a group that did not receive corticosteroids. We included studies in children, from birth up to 18 years of age, including preterm infants, undergoing cardiac surgery with the use of CPB. We also excluded studies in patients undergoing heart or lung transplantation, or both; studies in patients already receiving corticosteroids; in patients with abnormalities of the hypothalamic-pituitary-adrenal axis; and in patients given steroids at the time of cardiac surgery for indications other than cardiac surgery. DATA COLLECTION AND ANALYSIS: We used the Covidence systematic review manager to extract and manage data for the review. Two review authors independently assessed studies for inclusion, extracted data, and assessed risks of bias. We resolved disagreements by consensus or by consultation with a third review author. We assessed the certainty of evidence with GRADE. MAIN RESULTS: We found 3748 studies, of which 888 were duplicate records. Two studies had the same clinical trial registration number, but reported different populations and interventions. We therefore included them as separate studies. We screened titles and abstracts of 2868 records and reviewed full text reports for 84 studies to determine eligibility. We extracted data for 13 studies. Pooled analyses are based on eight studies. We reported the remaining five studies narratively due to zero events for both intervention and placebo in the outcomes of interest. Therefore, the final meta-analysis included eight studies with a combined population of 478 participants. There was a low or unclear risk of bias across the domains. There was moderate certainty of evidence that corticosteroids do not change the risk of in-hospital mortality (five RCTs; 313 participants; risk ratio (RR) 0.83, 95% confidence interval (CI) 0.33 to 2.07) for children undergoing cardiac surgery with CPB. There was high certainty of evidence that corticosteroids reduce the duration of mechanical ventilation (six RCTs; 421 participants; mean difference (MD) 11.37 hours lower, 95% CI -20.29 to -2.45) after the surgery. There was high-certainty evidence that the intervention probably made little to no difference to the length of postoperative intensive care unit (ICU) stay (six RCTs; 421 participants; MD 0.28 days lower, 95% CI -0.79 to 0.24) and moderate-certainty evidence that the intervention probably made little to no difference to the length of the postoperative hospital stay (one RCT; 176 participants; mean length of stay 22 days; MD -0.70 days, 95% CI -2.62 to 1.22). There was moderate certainty of evidence for no effect of the intervention on all-cause mortality at the longest follow-up (five RCTs; 313 participants; RR 0.83, 95% CI 0.33 to 2.07) or cardiovascular mortality at the longest follow-up (three RCTs; 109 participants; RR 0.40, 95% CI 0.07 to 2.46). There was low certainty of evidence that corticosteroids probably make little to no difference to children separating from CPB (one RCT; 40 participants; RR 0.20, 95% CI 0.01 to 3.92). We were unable to report information regarding adverse events of the intervention due to the heterogeneity of reporting of outcomes. We downgraded the certainty of evidence for several reasons, including imprecision due to small sample sizes, a single study providing data for an individual outcome, the inclusion of both appreciable benefit and harm in the confidence interval, and publication bias. AUTHORS' CONCLUSIONS: Corticosteroids  probably do not change the risk of mortality for children having heart surgery using CPB at any time point. They probably reduce the duration of postoperative ventilation in this context, but have little or no effect on the total length of postoperative ICU stay or total postoperative hospital stay. There was inconsistency in the adverse event outcomes reported which, consequently, could not be pooled. It is therefore impossible to provide any implications and policy-makers will be unable to make any recommendations for practice without evidence about adverse effects. The review highlighted the need for well-conducted RCTs powered for clinical outcomes to confirm or refute the effect of corticosteroids versus placebo in children having cardiac surgery with CPB. A core outcome set for adverse event reporting in the paediatric major surgery and intensive care setting is required.

COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines' Side Effects.

BACKGROUND: Coronavirus disease (COVID-19) vaccine-related side effects have a determinant role in the public decision regarding vaccination. Therefore, this study has been designed to actively monitor the safety and effectiveness of COVID-19 vaccines globally. METHODS: A multi-country, three-phase study including a cross-sectional survey to test for the short-term side effects of COVID-19 vaccines among target population groups. In the second phase, we will monitor the booster doses' side effects, while in the third phase, the long-term safety and effectiveness will be investigated. A validated, self-administered questionnaire will be used to collect data from the target population; Results: The study protocol has been registered at ClinicalTrials.gov, with the identifier NCT04834869. CONCLUSIONS: CoVaST is the first independent study aiming to monitor the side effects of COVID-19 vaccines following booster doses, and the long-term safety and effectiveness of said vaccines.

Multisystemic Inflammatory Syndrome in Children Associated With SARS-CoV-2 Infection: A Case Series Report in a Pediatric Center in Mexico.

We report four cases of patients with multisystem inflammatory syndrome in children (MIS-C) associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, of which three patients presented characteristics of Kawasaki disease (KD). All presented fever of more than 3 days, and gastrointestinal involvement, significant increase in C-reactive protein (CRP), polymorphonuclear cells, procalcitonin, D-dimer, fibrinogen and troponin, lymphopenia and hypoalbuminemia. Myocardial involvement was observed in two patients. All were treated with fluids resuscitation and vasoactive therapy, 75% received intravenous immunoglobulin (IVIG) and systemic steroids. Two patients developed a transient acute kidney injury, one patient presented as acute appendicitis and developed a bilateral pleural effusion. One patient required a second dose of IVIG and boluses of methylprednisolone. None required mechanical ventilation and there were no deaths.

Clinical and epidemiological characteristics of children with SARS-CoV-2 infection: a case series in Sinaloa.

Background: The SARS-CoV-2 virus may affect both adults and children. Although COVID-19 has a lower prevalence in infancy and has been described as mild, the clinical characteristics may vary, and there is a possibility of complications. The objectives of this study were to describe the clinical and epidemiological aspects of confirmed COVID-19 pediatric cases in the state of Sinaloa, Mexico, during the first 3 months of the pandemic, and children admitted with COVID-19 to a secondary hospital. Methods: This case series includes all patients with SARS-CoV-2 infection confirmed by PCR (polymerase chain reaction) test, identified in the state epidemiological surveillance system (SISVER) between March 1 and May 31, 2020. Confirmed patients admitted to the Sinaloa Pediatric Hospital (HPS) in the same period are also described. Results: Fifty-one children with SARS-CoV-2 were included, of which ten were admitted to the HPS. The median age was 10 years. The more frequent symptoms were fever (78%), cough (67%), and headache (57%). Most cases were mild or asymptomatic. Three patients with comorbidities died. Only four of ten patients identified in HPS were admitted with the diagnosis of possible COVID-19. Conclusions: SARS-CoV-2 infection in children was mostly mild or asymptomatic, and the clinical presentation varied. There is a possibility of complications, especially in children with comorbidities.

Introducción: El SARS-CoV-2 puede afectar tanto a adultos como a niños. Aunque la COVID-19 presenta menor prevalencia en la infancia y se ha descrito como leve, las características clínicas pueden ser variables y existe la posibilidad de complicaciones. Los objetivos de este estudio fueron describir las características clínicas y epidemiológicas de los casos pediátricos confirmados en el Estado de Sinaloa, México, durante los primeros 3 meses de la pandemia, y de los niños con COVID-19 internados en un hospital de segundo nivel. Métodos: Esta serie de casos incluyó pacientes con infección por SARS-CoV-2 confirmados por prueba de reacción en cadena de la polimerasa (PCR), identificados en el Sistema de Vigilancia Epidemiológica de Enfermedades Respiratorias (SISVER) del 1 de marzo al 31 de mayo de 2020. Se describen también las características de todos los niños confirmados en el Hospital Pediátrico de Sinaloa (HPS) en las mismas fechas. Resultados: Se incluyeron 51 niños con infección por SARS-CoV-2, de los cuales 10 fueron internados en el HPS. La mediana de edad fue de 10 años. Los síntomas más frecuentes fueron fiebre (78%), tos (67%) y cefalea (57%). La mayoría de los casos fueron leves o asintomáticos. Tres pacientes con comorbilidad fallecieron. Solo cuatro de diez pacientes identificados en el HPS ingresaron bajo sospecha de COVID-19. Conclusiones: La infección por SARS-CoV-2 en los niños fue, en su mayoría, asintomática o leve, y la presentación fue variable. Existe la posibilidad de que se produzcan complicaciones, principalmente en niños con comorbilidad.