Objectives: Bacille Calmette-Guérin (BCG) vaccine has immunomodulatory effects that may provide protection against unrelated infectious diseases. We aimed to determine whether BCG vaccination protects adults against COVID-19.
Design: Phase III double-blind randomised controlled trial.
Background: The beneficial off-target effects of Bacille Calmette-Guérin (BCG) vaccination potentially include protection against allergy.
Objective: In the MIS BAIR trial, we aimed to determine whether neonatal BCG vaccination reduces atopic sensitisation and clinical food allergy in infants.
Methods: In this randomised controlled trial, 1272 neonates were allocated to BCG-Denmark vaccine (0.
Background: Bacille Calmette-Guérin (BCG) vaccination has off-target (non-specific) effects that are associated with protection against unrelated infections and decreased all-cause mortality in infants. We aimed to determine whether BCG vaccination prevents febrile and respiratory infections in adults.
Methods: This randomised controlled phase 3 trial was done in 36 healthcare centres in Australia, Brazil, the Netherlands, Spain, and the United Kingdom.
Background: Antibiotic exposure increases antimicrobial resistance and has also been associated with long-term harms, including allergies, inflammatory diseases and weight gain. We assessed antibiotic exposure in the first 2 years of life in Australian children, the factors influencing this and its appropriateness.
Methods: Data from 1201 participants in the MIS BAIR randomized controlled trial were used.
Purpose: Vosoritide is administered as a daily subcutaneous injection in children with achondroplasia. In clinical trials, families of children aged 2-4 years reported difficulty with drug administration due to child fear, pain, and distress. Study aims were to gain a better understanding of the current vosoritide administration experience in this cohort and to investigate whether topical anaesthesia and ice application prior to injections improved the child and family experience.
View Article and Find Full Text PDFBackground: Recurrences of herpes simplex virus (HSV) in the orofacial region (herpes labialis or cold sores) impact quality-of-life. We aimed to study whether the bacille Calmette-Guérin (BCG) vaccine can attenuate cold sore recurrences through off-target immunomodulatory effects.
Methods: In this nested randomised controlled trial within the multicentre, phase 3 BRACE trial, 6828 healthcare workers were randomised in 36 sites in Australia, the Netherlands, Spain, the United Kingdom and Brazil, to receive BCG-Denmark or no BCG (1:1 ratio using a web-based procedure) and followed for 12 months with 3-monthly questionnaires.
Background: The bacille Calmette-Guérin (BCG) vaccine has immunomodulatory "off-target" effects that have been hypothesized to protect against coronavirus disease 2019 (Covid-19).
Methods: In this international, double-blind, placebo-controlled trial, we randomly assigned health care workers to receive the BCG-Denmark vaccine or saline placebo and followed them for 12 months. Symptomatic Covid-19 and severe Covid-19, the primary outcomes, were assessed at 6 months; the primary analyses involved the modified intention-to-treat population, which was restricted to participants with a negative test for severe acute respiratory syndrome coronavirus 2 at baseline.
Background: This study aims to describe the use of a paediatric advice line (PAL) provided to parents whose infants were recruited to a large randomised controlled trial (RCT), including the number and types of medical concerns addressed, seasonal variability and call outcomes. Additionally, sociodemographic characteristics of the parents and children of those parents who used the PAL are compared with those who did not.
Methods: Prospective cohort of 1246 children nested in the Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR) RCT.
Background: Empiric vancomycin dosing regimens fail to achieve recommended target trough concentrations of 10-20 mg/L in the majority of infants. This study assessed the performance of a model-based dosing calculator (Vanc App) in achieving target vancomycin concentrations at first steady-state level.
Methods: This was a multicenter prospective study in four tertiary pediatric hospitals over an 18-month period.
Pediatr Infect Dis J
July 2022
We report a case of Mycobacterium avium complex infection of the retropharyngeal space in a 20-month-old girl. We also summarize the published literature on the pathogenesis and management of nontuberculous mycobacterial infections of the retropharynx.
View Article and Find Full Text PDFBackground: There is no standardized definition for infant eczema, and various tools have been used across studies, precluding direct comparison.
Objective: The aim of the study was to assess and to compare the accuracy of diagnostic tools for infant eczema using the extensive data collected in Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR), an eczema prevention trial.
Methods: Eczema incidence was assessed by 3 questionnaire-based measures: modified UK diagnostic tool, parent-reported medically diagnosed eczema, and parent-reported use of topical corticosteroids.
Introduction: BCG vaccination modulates immune responses to unrelated pathogens. This off-target effect could reduce the impact of emerging pathogens. As a readily available, inexpensive intervention that has a well-established safety profile, BCG is a good candidate for protecting healthcare workers (HCWs) and other vulnerable groups against COVID-19.
View Article and Find Full Text PDFBackground: Bacille Calmette-Guérin (BCG) vaccine could play a role in counteracting the rising prevalence of atopic diseases, through its beneficial off-target effects. We aimed to determine whether neonatal BCG vaccination reduces the incidence of eczema in infants.
Methods: Randomized controlled trial with 1272 infants allocated to receive BCG-Denmark or no BCG at birth.
Background: Bacille Calmette-Guérin (BCG) vaccination has beneficial off-target effects that may include protecting against non-mycobacterial infectious diseases. We aimed to determine whether neonatal BCG vaccination reduces lower respiratory tract infections (LRTI) in infants in the Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR) trial.
Methods: In this investigator-blinded trial, neonates in Australia were randomized to receive BCG-Denmark vaccination or no BCG at birth.
Background: BCG vaccination has beneficial nonspecific (heterologous) effects that protect against nonmycobacterial infections. We have previously reported that BCG vaccination at birth alters in vitro cytokine responses to heterologous stimulants in the neonatal period. This study investigated heterologous responses in 167 infants in the same trial 7 months after randomization.
View Article and Find Full Text PDFIntroduction: BCG vaccination reduces all-cause infant mortality in high-mortality settings by more than can be attributed to protection against tuberculosis. This is proposed to result from non-specific protection against non-vaccine targeted ('off-target') infections. There is also evidence that BCG protects against allergic diseases.
View Article and Find Full Text PDFJ Clin Tuberc Other Mycobact Dis
August 2019
The tuberculin skin test and interferon-gamma release assays have limitations in diagnosing tuberculosis (TB), particularly in children. This study investigated the performance of candidate -specific cytokine biomarkers for TB in children in a TB-endemic setting. A total of 237 children with a household contact with smear-positive pulmonary TB were recruited.
View Article and Find Full Text PDFBackground: In adults, continuous infusions of vancomycin (CIV) are associated with earlier attainment of target drug concentrations, require fewer blood samples for monitoring, and may reduce drug toxicity. We aimed to determine, in young infants, if CIV or intermittent infusions of vancomycin (IIV) better achieves target vancomycin concentrations at the first steady-state level and to compare the frequency of drug-related adverse effects.
Methods: In a multicenter randomized controlled trial in 2 tertiary neonatal units over a 40-month period, young infants aged 0 to 90 days requiring vancomycin therapy for at least 48 hours were randomly assigned to CIV and IIV.
Background: BCG vaccination is associated with a reduction in all-cause infant mortality in high-mortality settings. The underlying mechanisms remain uncertain, but long-term modulation of the innate immune response (trained immunity) may be involved.
Methods: Whole-blood specimens, collected 7 days after randomization from 212 neonates enrolled in a randomized trial of neonatal BCG vaccination, were stimulated with killed pathogens and Toll-like receptor (TLR) ligands to interrogate cytokine responses.
Background: Bell's palsy or acute idiopathic lower motor neurone facial paralysis is characterized by sudden onset paralysis or weakness of the muscles to one side of the face controlled by the facial nerve. While there is high level evidence in adults demonstrating an improvement in the rate of complete recovery of facial nerve function when treated with steroids compared with placebo, similar high level studies on the use of steroids in Bell's palsy in children are not available. The aim of this study is to assess the utility of steroids in Bell's palsy in children in a randomised placebo-controlled trial.
View Article and Find Full Text PDFAim: The aetiology and clinical course of Bell's palsy may be different in paediatric and adult patients. There is no randomised placebo controlled trial (RCT) to show effectiveness of prednisolone for Bell's palsy in children. The aim of the study was to assess current practice in paediatric Bell's palsy in Australia and New Zealand Emergency Departments (ED) and determine the feasibility of conducting a multicentre RCT within the Paediatric Research in Emergency Departments International Collaborative (PREDICT).
View Article and Find Full Text PDFJ Paediatr Child Health
September 2015
Aim: To determine the period prevalence and nature of complementary and alternative medicine (CAM) use among paediatric emergency department (ED) patients and the perceptions of CAM among the CAM administrators.
Methods: A survey was undertaken in four Victorian EDs (January to September 2013). A convenience sample of parents/carers accompanying paediatric patients completed a self-administered questionnaire.