Protocol for a multisite randomised controlled trial assessing the effect of the Telehealth for Early Developmental Intervention in babies born very preterm (TEDI-Prem) programme on neurodevelopmental outcomes and parent well-being.

Introduction: Infants born very preterm (VPT, <32 weeks' gestation) are at increased risk for neurodevelopmental impairments including motor, cognitive and behavioural delay. Parents of infants born VPT also have poorer mental health outcomes compared with parents of infants born at term.We have developed an intervention programme called TEDI-Prem (Telehealth for Early Developmental Intervention in babies born very preterm) based on previous research.

Protocol for an embedded randomised controlled trial of Early versus Late Stopping of Antibiotics in children with Febrile Neutropenia (ELSA-FN).

In children with cancer, febrile neutropenia (FN) is one of the most common complications of treatment, a leading cause of unplanned and prolonged hospital admission and is the key driver of antibiotic exposure. Co-designed with key stakeholders, 'Early versus Late Stopping of Antibiotics in high-risk FN' (ELSA-FN) is a randomised controlled, non-inferiority trial that compares stopping antibiotics in clinically stable patients after 48 hours with the current standard of care, continuing antibiotics until absolute neutrophil recovery. As an Australian first, we will exploit the potential of electronic medical record (EMR) systems, embedding all key aspects of the trial including screening, consent, randomisation and data collection into standard clinical and EMR workflows.

Chewing gum to treat postoperative nausea and vomiting in female patients: a multicenter randomized trial.

Background: Postoperative nausea and vomiting (PONV) is common after general anesthesia, with consequences for patient outcomes, satisfaction with care and healthcare costs. Our aim was to compare a new treatment, chewing gum, with a widely-used intravenous agent, ondansetron, to treat PONV in female patients in the post anesthesia care unit (PACU).

Methods: We conducted a multicenter, randomized, controlled non-inferiority trial in 17 hospitals in Australia and New Zealand.

The seroprevalence of SARS-CoV-2-specific antibodies in Australian children: A cross-sectional study.

Background: Following reduction of public health and social measures concurrent with SARS-CoV-2 Omicron emergence in late 2021 in Australia, COVID-19 case notification rates rose rapidly. As rates of direct viral testing and reporting dropped, true infection rates were most likely to be underestimated.

Objective: To better understand infection rates and immunity in this population, we aimed to estimate SARS-CoV-2 seroprevalence in Australians aged 0-19 years.

Short-term Outcomes in Infants after General Anesthesia with Low-dose Sevoflurane/Dexmedetomidine/Remifentanil versus Standard-dose Sevoflurane (the TREX Trial).

Background: The Trial Remifentanil DEXmedetomidine (TREX) trial aimed to determine whether, in children less than 2 yr old, low-dose sevoflurane/dexmedetomidine/remifentanil anesthesia is superior to standard-dose sevoflurane anesthesia in terms of global cognitive function at 3 yr of age. The aim of the current secondary analyses was to compare incidence of intraoperative hypotension and bradycardia, postoperative pain, time to recovery, need for treatment of intraoperative hypotension and bradycardia, incidence of light anesthesia and need for treatment, need for postoperative pain medications, and morbidity and mortality outcomes at 5 days between the two arms.

Methods: This phase III randomized active controlled, parallel group, assessor blinded, multicenter, superiority trial was performed in 20 centers in Australia, Italy, and the United States.

Associations with early vomiting when using intranasal fentanyl and nitrous oxide for procedural sedation in children: A secondary analysis of a randomised controlled trial.

Objective: Intranasal (IN) fentanyl and nitrous oxide (NO) can be combined to provide procedural sedation and analgesia to children. This combination is advantageous because of rapid onset of action and non-parenteral administration, but is associated with increased vomiting. We sought to describe the associations of demographic and procedural factors with early vomiting when using this combination in children.

Embedding nurse home visiting in universal healthcare: 6-year follow-up of a randomised trial.

Objective: Nurse home visiting (NHV) is designed to redress child and maternal health inequities. Of the previous trials to investigate NHV benefits beyond preschool, none were designed for populations with universal healthcare. To address this evidence gap, we investigated whether the Australian 'right@home' NHV programme improved child and maternal outcomes when children turned 6 and started school.

The Australian evidence-based clinical practice guideline for attention deficit hyperactivity disorder.

Objective: The objective of this article was to provide an overview of the development and recommendations from the Australian evidence-based clinical practice guideline for attention deficit hyperactivity disorder (ADHD). The guideline aims to promote accurate and timely identification and diagnosis, and optimal and consistent treatment of ADHD.

Methods: Development integrated the best available evidence with multidisciplinary clinical expertise and the preferences of those with lived experience, underpinned by the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework.

Randomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care Workers.

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.

Pharmacological emergency management of agitation in children and young people: protocol for a randomised controlled trial of oral medication (PEAChY-O).

Introduction: Acute severe behavioural disturbance (ASBD) is a condition seen with increasing frequency in emergency departments (EDs) in adults and young people. Despite the increasing number of presentations and significant associated risks to patients, families and caregivers, there is limited evidence to guide the most effective pharmacological management in children and adolescents. The aim of this study is to determine whether a single dose of oral olanzapine is more effective than a dose of oral diazepam at successfully sedating young people with ASBD.

Pharmacological Emergency management of Agitation in Children and Young people: protocol for a randomised controlled trial of intraMuscular medication (PEAChY-M).

Introduction: Acute severe behavioural disturbance (ASBD) is a condition seen with increasing frequency in emergency departments (EDs) in adults and young people. Despite the increasing number of presentations and significant associated risks to patients, families and caregivers, there is limited evidence to guide the most effective pharmacological management in children and adolescents. The aim of this study is to determine whether a single dose of intramuscular olanzapine is more effective than intramuscular droperidol at successfully sedating young people with ASBD requiring intramuscular sedation.

Adverse effects of antibiotics in children with cancer: are short-course antibiotics for febrile neutropenia part of the solution?

Introduction: Febrile neutropenia is a common complication experienced by children with cancer or those undergoing hematopoietic stem cell transplantation. Repeated episodes of febrile neutropenia result in cumulative exposure to broad-spectrum antibiotics with potential for a range of serious adverse effects. Short-course antibiotics, even in patients with high-risk febrile neutropenia, may offer a solution.

Individualized vancomycin dosing in infants: prospective evaluation of an online dose calculator.

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.

Nurse home visiting to improve child and maternal outcomes: 5-year follow-up of an Australian randomised controlled trial.

Objectives: Nurse home visiting (NHV) is widely implemented to address inequities in child and maternal health. However, few studies have examined longer-term effectiveness or delivery within universal healthcare systems. We evaluated the benefits of an Australian NHV program ("right@home") in promoting children's language and learning, general and mental health, maternal mental health and wellbeing, parenting and family relationships, at child ages 4 and 5 years.

Prevalence of high flow nasal cannula therapy use for management of infants with bronchiolitis in Australia and New Zealand.

Aim: To determine the prevalence of high flow nasal cannula (HFNC) therapy in infants presenting to hospital in Australia and New Zealand with bronchiolitis over four bronchiolitis seasons. Secondary aims were to determine temporal trends in HFNC use, and associations between HFNC, hospital length of stay (LOS) and intensive care unit (ICU) admission.

Methods: A planned sub-study of a multi-centre international cluster randomised controlled trial investigating knowledge translation strategies for a bi-national bronchiolitis guideline.

Sustainability of evidence-based practices in the management of infants with bronchiolitis in hospital settings - a PREDICT study protocol.

Background: Understanding how and why de-implementation of low-value practices is sustained remains unclear. The Paediatric Research in Emergency Departments International CollaboraTive (PREDICT) Bronchiolitis Knowledge Translation (KT) Study was a cluster randomised controlled trial conducted in 26 Australian and New Zealand hospitals (May-November 2017). Results showed targeted, theory-informed interventions (clinical leads, stakeholder meetings, train-the-trainer workshop, targeted educational package, audit/feedback) were effective at reducing use of five low-value practices for bronchiolitis (salbutamol, glucocorticoids, antibiotics, adrenaline and chest x-ray) by 14.

Implications of providing wrist-hand orthoses for children with cerebral palsy: evidence from a randomised controlled trial.

Purpose: To investigate the effects of providing rigid wrist-hand orthoses plus usual multidisciplinary care, on reducing hand impairments in children with cerebral palsy.

Methods: A pragmatic, multicentre, assessor-blinded randomised controlled trial aimed to enrol 194 children aged 5-15 years, with wrist flexor Modified Ashworth Scale score ≥1. Randomisation with concealed allocation was stratified by study site and passive wrist range.

Economic evaluation of an Australian nurse home visiting programme: a randomised trial at 3 years.

Objectives: To investigate the additional programme cost and cost-effectiveness of 'right@home' Nurse Home Visiting (NHV) programme in relation to improving maternal and child outcomes at child age 3 years compared with usual care.

Design: A cost-utility analysis from a government-as-payer perspective alongside a randomised trial of NHV over 3-year period. Costs and quality-adjusted life-years (QALYs) were discounted at 5%.

Can targeted interventions change the factors influencing variation in management of infants with bronchiolitis? A survey of Australian and New Zealand clinicians: A paediatric research in emergency departments international collaborative (PREDICT) study.

Aim: This study aimed to determine whether targeted interventions, proven to be effective at improving evidence-based bronchiolitis management, changed factors previously found to influence variation in bronchiolitis management.

Methods: This survey assessed change in factors influencing clinicians' (nurses and doctors) bronchiolitis management at baseline and post-intervention in a cluster randomised controlled trial of targeted, theory-informed interventions aiming to de-implement non-evidence-based bronchiolitis management (no use of chest X-ray, salbutamol, antibiotics, glucocorticoids and adrenaline). Survey questions addressed previously identified factors influencing bronchiolitis management from six Theoretical Domains Framework domains (knowledge; skills; beliefs about consequences; social/professional role and identity; environmental context and resources; social influences).

Task-specific training for bicycle-riding goals in ambulant children with cerebral palsy: a randomized controlled trial.

Aim: To determine whether a task-specific physiotherapist-led training approach is more effective than a non-specific parent-led home programme for attaining bicycle-riding goals in ambulant children with cerebral palsy (CP).

Method: Sixty-two ambulant children with CP aged 6 to 15 years (33 males, 29 females, mean age 9y 6mo) with bicycle-riding goals participated in this multi-centre, assessor-blind, parallel-group, superiority randomized controlled trial. Children in the task-specific group participated in a physiotherapist-led, group-based, intensive training programme.

Study protocol of a phase 2, dual-centre, randomised, controlled trial evaluating the effectiveness of probiotic and egg oral immunotherapy at inducing desensitisation or sustained unresponsiveness (remission) in participants with egg allergy compared with placebo (Probiotic Egg Allergen Oral Immunotherapy for Treatment of Egg Allergy: PEAT study).

Introduction: Egg allergy is the most common food allergy in children but recent studies have shown persistence or delayed resolution into adolescence. As there is currently no effective long-term treatment, definitive treatments that improve quality of life and prevent fatalities for food allergies are required. We have previously shown that a novel treatment comprising a combination of the probiotic CGMCC 1.