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Children need rich language learning experiences in school to build language and reading skills. Research suggests that various effective ways to support teacher provision of these experiences. The Classroom Promotion of Oral Language cluster randomized controlled trial (n = 1,360 students; 687 intervention, 673 control) examined whether a teacher professional learning intervention targeting oral language in the first years of school led to improved student outcomes compared to usual teaching practices. The intervention comprised face-to-face professional learning and ongoing support. The primary outcome was student reading ability at Grade 3; secondary outcomes included oral language, reading, and mental health at Grades 1 and 3. No differences were detected between the intervention and control arms. Implications of results and future directions are explored.

Teacher classroom instructional practice can be a powerful influence on student learning. The Classroom Promotion of Oral Language randomized controlled trial tested whether teacher professional learning focused on promoting oral language in classrooms could improve teacher knowledge and classroom instruction. This study focuses on evaluating the impact of the professional learning on teacher classroom instruction. The nature of classroom talk was used as a means of exploring theories of change and the pathways to practice change. Classroom talk was classified according to its function; organisational, doing, and learning. Teachers from early years classes (first 2 years of school) participated in 4 days of professional learning and received implementation support in their school. Teacher instruction was measured through audio-recordings of classroom talk between teachers and students. The characteristics and proportions of the functions of classroom talk demonstrated by teachers who participated in professional learning (n = 40) and those who did not (n = 38) were compared. Findings indicated no differences in the functions of classroom talk measured with Anstey's type of talk framework following participation in the professional learning; similarities in classroom instruction are discussed and implications for professional learning.

Teacher knowledge is a critical factor in student success. In the Classroom Promotion of Oral Language cluster randomized controlled trial, we aimed to determine whether a teacher professional learning intervention focused on promoting oral language led to improved teacher knowledge. We report a study of the impact of professional learning on teacher knowledge of oral language and literacy constructs. The intervention comprised four days of face-to-face professional learning for early years' teachers, and ongoing school implementation support. Teacher knowledge was measured through a survey at baseline, 12 months and 24 months (n = 40 intervention, n = 38 control). Teachers in the intervention arm made more correct responses on survey items than teachers in the control arm, at both time points. The professional learning intervention improved teacher knowledge in the short-to-medium term.

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. Setting and participants: Randomised controlled trial of NHV delivered via universal, child and family health services (the comparator). Pregnant women experiencing adversity (≥2 of 10 risk factors) were recruited from 10 antenatal clinics across 2 states (Victoria, Tasmania) in Australia. Intervention: Mothers in the intervention arm were offered 25 nurse home visits (mean 23·2 home visits [SD 7·4, range 1–43] received) of 60–90 minutes, commencing antenatally and continuing until children's second birthdays. Primary and secondary outcomes measured: At 4 and 5 years, outcomes were assessed via parent interview and direct assessment of children's language and learning (receptive and expressive language, phonological awareness, attention, and executive function). Outcomes were compared between intervention and usual care arms (intention to treat) using adjusted regression with robust estimation to account for nurse/site. Missing data were addressed using multiple imputation and inverse probability weighting. Results: Of 722 women enrolled in the trial, 225 of 363 (62%) intervention and 201 of 359 (56%) usual care women provided data at 5 years. Estimated group differences showed an overall pattern favouring the intervention. Statistical evidence of benefits was found across child and maternal mental health and wellbeing, parenting and family relationships with effect sizes ranging 0·01–0·27. Conclusion: An Australian NHV program promoted longer-term family functioning and wellbeing for women experiencing adversity. NHV can offer an important component of a proportionate universal system that delivers support and intervention relative to need. Trial registration: 2013–2016, registration ISRCTN89962120 [ABSTRACT FROM AUTHOR]

Background: Gabapentin is often used to manage pain in children with dystonic cerebral palsy, however the evidence for its effectiveness in this population is limited. The primary objective of this feasibility pilot study was to assess the factors which might impact on a future randomised controlled trial including the ability to recruit and retain participants, assess adherence/compliance to the prescribed intervention, and ability to complete all outcome assessments. The secondary objective was to gather preliminary evidence for the effectiveness of gabapentin at reducing pain, improving comfort and reducing dystonia in children with dystonic cerebral palsy.Methods: This open label pilot study recruited children aged 5-18 years with dystonic cerebral palsy and accompanying pain affecting daily activities from four centres around Australia. Children were prescribed gabapentin for 12 weeks and were assessed at baseline, 6 weeks and 12 weeks. The primary outcome was feasibility of the protocol. Secondary outcomes were pain behaviour, pain intensity, care and comfort, individualised goal setting and dystonia severity.Results: Thirteen children (mean age 10.4 years (SD 2.4yrs), 9 females) were recruited from 71 screened over 15 months. Two children withdrew while eight children experienced side effects. There were issues with adherence to medication dosage regimens and data collection. Improvements were seen in pain behaviour, comfort and pain related goals at 12 weeks. Dystonia was not significantly changed.Conclusions: Whilst gabapentin has potential to improve pain and comfort in children with dystonic CP, the feasibility of implementing a definitive randomised controlled trial is low. Alternative trials designs are required to further examine the effectiveness of gabapentin in this heterogeneous population.Trial Registration: The trial was registered with the Australian Clinical Trial Registry ( ACTRN12616000366459 ) on 22/03/2016 and the Therapeutic Goods Administration (CT-2016-CTN-00500-1) on 22/06/2016. [ABSTRACT FROM AUTHOR]

Aim: Pain associated with immunisations can result in distress and/or anxiety for children and parents. We assessed the feasibility and acceptability of two novel devices; Coolsense (cold) and Buzzy (vibration ± cooling pads) versus standard care to minimise pain during immunisations. We also evaluated compliance to the devices and parent's perception of the effectiveness of the devices/standard care for minimising pain during immunisation.Design: Open label, pilot, randomised controlled trial (RCT).Methods: Forty children aged 3.5 to 6 years attending an Immunisation Centre at The Royal Children's Hospital in Melbourne, Australia, were randomised (1:1:1:1) into four groups: (i) Coolsense plus standard care; (ii) Buzzy with cold plus standard care; (iii) Buzzy without cold plus standard care; and (iv) Standard care alone (distraction with bubbles).Results and Analysis: Recruitment was completed in 12 days. Seventy percent were compliant with Buzzy (±cold), 82% with Coolsense, and 60% with standard care. Buzzy (with cold) was identified as effective by 70% of parents, Coolsense by 64%, Buzzy without cold by 50% and standard care by 60%.Conclusions: This pilot study demonstrated feasibility. A larger RCT is needed to provide definitive evidence to inform best practice for minimising immunisation pain in young children. [ABSTRACT FROM AUTHOR]

Background: This paper presents drinking patterns in a prospective study of a population-based cohort of 1570 pregnant women using a combination of dose and timing to give best estimates of prenatal alcohol exposure (PAE). Novel assessments include women's special occasion drinking and alcohol use prior to pregnancy recognition.Methods: Information on up to nine types of alcoholic drink, with separate frequencies and volumes, including drinking on special occasions outside a 'usual' pattern, was collected for the periconceptional period and at four pregnancy time points. Weekly total and maximum alcohol consumption on any one occasion was calculated and categorised. Drinking patterns are described in the context of predictive maternal characteristics.Results: 41.3 % of women did not drink during pregnancy, 27 % drank in first trimester only; most of whom stopped once they realised they were pregnant (87 %). When compared to women who abstained from alcohol when pregnant, those who drank in the first trimester only were more likely to have an unplanned pregnancy and not feel the effects of alcohol quickly. Almost a third of women continued to drink alcohol at some level throughout pregnancy (27 %), around half of whom never drank more than at low or moderate levels. When compared with abstainers and to women who only drank in trimester one, those who drank throughout pregnancy tended to be in their early to mid-thirties, smoke, have a higher income and educational attainment. Overall, almost one in five women (18.5 %) binge drank prior to pregnancy recognition, a third of whom were identified with a question about 'special occasion' drinking. Women whose age at first intoxication was less than 18 years (the legal drinking age in Australia), were significantly more likely to drink in pregnancy and at binge levels prior to pregnancy recognition.Conclusions: We have identified characteristics of pregnant women who either abstain, drink until pregnancy awareness or drink throughout pregnancy. These may assist in targeting strategies to enhance adherence to an abstinence policy and ultimately allow for appropriate follow-up and interpretation of adverse child outcomes. Our methodology also produced important information to reduce misclassification of occasional binge drinking episodes and ensure clearly defined comparison groups. [ABSTRACT FROM AUTHOR]

BACKGROUND: Poor mental health is recognized as one of the greatest global burdens of disease. Maternal mental health is crucial for the optimal health of mothers and their children. We examined the effects of an Australian Nurse Home Visiting (NHV) program (right@home), offered to pregnant women experiencing adversity, on maternal mental health and well-being at child age 3 years. METHODS: A randomized controlled trial of NHV delivered via universal child and family health services (2013-2016). Pregnant women experiencing adversity (≥2 of 10 risk factors) were recruited from 10 antenatal clinics across 2 states. Intervention comprised 25 home visits until child age 2 years. The outcomes assessed 1-year postintervention completion were maternal self-report of mental health symptoms (Depression Anxiety Stress Scales) and positive aspects of mental health (personal well-being and self-efficacy). RESULTS: Of the 722 women enrolled in the trial, 255 of 363 (70%) intervention and 240 of 359 (67%) control group women provided data at 3 years. Compared with controls, the intervention group reported better mental health (reverse Depression Anxiety Stress Scales scores): effect sizes of 0.25 (depression; 95% confidence interval [CI]: 0.08 to 0.32), 0.20 (anxiety; 95% CI: 0.05 to 0.30), 0.17 (stress; 95% CI: 0.09 to 0.37), and 0.23 (total score; 95% CI: 0.12 to 0.38); 0.16 (95% CI: 0.04 to 0.29) for personal well-being; and an odds ratio of 1.60 (95% CI: 1.19 to 2.16) for self-efficacy. CONCLUSIONS: An NHV designed to support mothers experiencing adversity can lead to later maternal mental health benefits, even after the program ends. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Nurse home visiting (NHV) may redress inequities in children's health and development evident by school entry. We tested the effectiveness of an Australian NHV program (right@home), offered to pregnant women experiencing adversity, hypothesizing improvements in (1) parent care, (2) responsivity, and (3) the home learning environment at child age 2 years. METHODS: A randomized controlled trial of NHV delivered via universal child and family health services was conducted. Pregnant women experiencing adversity (>2 of 10 risk factors) with sufficient English proficiency were recruited from antenatal clinics at 10 hospitals across 2 states. The intervention comprised 25 nurse visits to child age 2 years. Researchers blinded to randomization assessed 13 primary outcomes, including Home Observation of the Environment (HOME) Inventory (6 subscales) and 25 secondary outcomes. RESULTS: Of 1427 eligible women, 722 (50.6%o) were randomly assigned; 306 of 363 (84%) women in the intervention and 290 of 359 (81%) women in the control group provided 2-year data. Compared with women in the control group, those in the intervention reported more regular child bedtimes (adjusted odds ratio 1.76; 95% confidence interval [CI] 1.25 to 2.48), increased safety (adjusted mean difference [AMD] 0.22; 95% CI 0.07 to 0.37), increased warm parenting (AMD 0.09; 95% CI 0.02 to 0.16), less hostile parenting (reverse scored; AMD 0.29; 95% CI 0.16 to 0.41), increased HOME parental involvement (AMD 0.26; 95% CI 0.14 to 0.38), and increased HOME variety in experience (AMD 0.20; 95% CI 0.07 to 0.34). CONCLUSIONS: The right@home program improved parenting and home environment determinants of children's health and development. With replicability possible at scale, it could be integrated into Australian child and family health services or trialed in countries with similar child health services. [ABSTRACT FROM AUTHOR]

BACKGROUND AND OBJECTIVES: Data from clinical trials support the use of continuous positive airway pressure (CPAP) for initial respiratory management in preterm infants, but there is concern regarding the potential failure of CPAP support. We aimed to examine the incidence and explore the outcomes of CPAP failure in Australian and New Zealand Neonatal Network data from 2007 to 2013. METHODS: Data from inborn preterm infants managed on CPAP from the outset were analyzed in 2 gestational age ranges (25-28 and 29-32 completed weeks). Outcomes after CPAP failure (need for intubation <72 hours) were compared with those succeeding on CPAP using adjusted odds ratios (AORs). RESULTS: Within the cohort of 19 103 infants, 11 684 were initially managed on CPAP. Failure of CPAP occurred in 863 (43%) of 1989 infants commencing on CPAP at 25-28 weeks' gestation and 2061 (21%) of 9695 at 29-32 weeks. CPAP failure was associated with a substantially higher rate of pneumothorax, and a heightened risk of death, bronchopulmonary dysplasia (BPD) and other morbidities compared with those managed successfully on CPAP. The incidence of death or BPD was also increased: (25-28 weeks: 39% vs 20%, AOR 2.30, 99% confidence interval 1.71-3.10; 29-32 weeks: 12% vs 3.1%, AOR 3.62 [2.76-4.74]). The CPAP failure group had longer durations of respiratory support and hospitalization. CONCLUSIONS: CPAP failure in preterm infants is associated with increased risk of mortality and major morbidities, including BPD. Strategies to promote successful CPAP application should be pursued vigorously. [ABSTRACT FROM AUTHOR]

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., Methods: A screening survey identified pregnant women experiencing adversity from antenatal clinics across two states (Victoria, Tasmania). 722 were randomised: 363 to the right@home programme (25 visits promoting parenting and home learning environment) and 359 to usual care. Child measures at 6 years (first school year): Strengths and Difficulties Questionnaire (SDQ), Social Skills Improvement System (SSIS), Childhood Executive Functioning Inventory (CHEXI) (maternal/teacher-reported); general health and paediatric quality of life (maternal-reported) and reading/school adaptation items (teacher-reported). Maternal measures: Personal Well-being Index (PWI), Depression Anxiety Stress Scales, warm/hostile parenting, Child-Parent Relationship Scale (CPRS), emotional abuse and health/efficacy items. Following best-practice methods for managing missing data, outcomes were compared between groups (intention-to-treat) using regression models adjusted for stratification factors, baseline variables and clustering (nurse/site level)., Results: Mothers reported on 338 (47%) children, and teachers on 327 (45%). Patterns of group differences favoured the programme arm, with small benefits (effect sizes ranging 0.15-0.26) evident for SDQ, SSIS, CHEXI, PWI, warm parenting and CPRS., Conclusions: Four years after completing the right@home programme, benefits were evident across home and school contexts. Embedding NHV in universal healthcare systems from pregnancy can offer long-term benefits for families experiencing adversity., Trial Registration Number: ISRCTN89962120., Competing Interests: Competing interests: The 'right@home' sustained nurse home visiting trial is a research collaboration between the Australian Research Alliance for Children and Youth (ARACY); the Translational Research and Social Innovation (TReSI) Group at Western Sydney University and the Centre for Community Child Health (CCCH), which is a department of The Royal Children’s Hospital and a research group of Murdoch Children’s Research Institute. Ownership of the right@home implementation and support license, which is purchased by Australian state governments for roll out for fidelity support, is shared between institutes., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

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 14.1% in acute care settings. The primary aim of this study is to determine the sustainability (continued receipt of benefits) of these outcomes at intervention hospitals two-years after the removal of study supports. Secondary aims are to determine sustainability at one-year after removal of study support at intervention hospitals; improvements one-and-two years at control hospitals; and explore factors that influence sustainability at intervention hospitals and contribute to improvements at control hospitals., Methods: A mixed-methods study design. The quantitative component is a retrospective medical record audit of bronchiolitis management within 24 hours of emergency department (ED) presentations at 26 Australian (n = 20) and New Zealand (n = 6) hospitals, which participated in the PREDICT Bronchiolitis KT Study. Data for a total of 1800 infants from intervention and control sites (up to 150 per site) will be collected to determine if improvements (i.e., no use of all five low-value practices) were sustained two- years (2019) post-trial (primary outcome; composite score); and a further 1800 infants from intervention and control sites will be collected to determine sustained improvements one- year (2018) post-trial (secondary outcome). An a priori definition of sustainability will be used. The qualitative component will consist of semi-structured interviews with three to five key emergency department and paediatric inpatient medical and nursing staff per site (total n = 78-130). Factors that may have contributed to sustaining outcomes and/or interventions will be explored and mapped to an established sustainability framework., Discussion: This study will improve our understanding of the sustainability of evidence-based bronchiolitis management in infants. Results will also advance implementation science research by informing future de-implementation strategies to reduce low-value practices and sustain practice change in paediatric acute care., Trial Registration: Australian and New Zealand Clinical Trials Registry No: ACTRN12621001287820., (© 2022. The Author(s).)

Background: Oral immunotherapy is effective at inducing desensitisation to allergens and induces sustained unresponsiveness (ie, clinical remission) in a subset of patients, but causes frequent reactions. We aimed to investigate whether addition of a probiotic adjuvant improved the efficacy or safety of peanut oral immunotherapy., Methods: PPOIT-003, a multicentre, randomised, phase 2b trial, was conducted in three tertiary hospitals in Australia (Adelaide [SA], Melbourne [VIC], and Perth [WA]) in children aged 1-10 years, weighing more than 7 kg, with peanut allergy confirmed by a double-blind placebo-controlled food challenge (cumulative 4950 mg dose of peanut protein) and positive peanut skin prick test (≥3 mm) or peanut-specific IgE (≥0·35 kU/L). Children were randomly assigned (2:2:1) to receive probiotic and peanut oral immunotherapy (PPOIT), placebo probiotic and peanut oral immunotherapy (OIT), or placebo probiotic and placebo OIT (placebo) for 18 months, and were followed up until 12 months after completion of treatment. Oral immunotherapy consisted of increasing doses of peanut protein (commercially available food-grade 12% defatted peanut flour [50% peanut protein]) until a 2000 mg daily maintenance dose was reached. The probiotic adjuvant was a daily dose of 2 × 10 10 colony-forming units of the probiotic Lactobacillus rhamnosus ATCC 53103. Placebo immunotherapy comprised maltodextrin, brown food colouring, and peanut essence, and placebo probiotic was maltodextrin. Dual primary outcomes were 8-week sustained unresponsiveness, defined as no reaction to a cumulative dose of 4950 mg peanut protein at treatment completion and 8 weeks after treatment completion, in the PPOIT versus placebo groups and the PPOIT versus OIT groups, analysed by intention to treat. Safety endpoints were adverse events during the treatment phase, and peanut ingestion and reactions in the 12-month post-treatment period. This study is registered with the Australian New Zealand Clinical Trials Registry, 12616000322437., Findings: Between July 4, 2016, and Sept 21, 2020, 201 participants were enrolled and included in the intention-to-treat analysis. 36 (46%) of 79 children in the PPOIT group and 42 (51%) of 83 children in the OIT group achieved sustained unresponsiveness compared with two (5%) of 39 children in the placebo group (risk difference 40·44% [95% CI 27·46 to 53·42] for PPOIT vs placebo, p<0·0001), with no difference between PPOIT and OIT (-5·03% [-20·40 to 10·34], p=0·52). Treatment-related adverse events were reported in 72 (91%) of 79 children in the PPOIT group, 73 (88%) of 83 children in the OIT group, and 28 (72%) of 39 children in the placebo group. Exposure-adjusted incidence of adverse events was 10·58 in the PPOIT group, 11·36 in the OIT, and 2·09 in the placebo group (ratio 0·92 [95% CI 0·85 to 0·99] for PPOIT vs OIT, p=0·042; 4·98 [4·11-6·03] for PPOIT vs placebo, p<0·0001; 5·42 [4·48-6·56] for OIT vs placebo, p<0·0001), with differences seen primarily in gastrointestinal symptoms and in children aged 1-5 years. During the 12-month post-treatment period, 60 (85%) of 71 participants in the PPOIT group, 60 (86%) of 70 participants in the OIT group, and six (18%) of 34 participants in the placebo group were eating peanut; rescue epinephrine use was infrequent (two [3%] of 71 in the PPOIT group, four [6%] of 70 in the OIT group, and none in the placebo group)., Interpretation: Both PPOIT and OIT were effective at inducing sustained unresponsiveness. Addition of a probiotic did not improve efficacy of OIT, but might offer a safety benefit compared with OIT alone, particularly in preschool children., Funding: National Health and Medical Research Council Australia and Prota Therapeutics., Competing Interests: Declaration of interests MDO'S reports having received grants from the Government of Western Australia Department of Health and Channel 7 Telethon Trust and is a director of the Australasian Society of Clinical Immunology and Allergy (ASCIA). PQ reports having received grants from DBV Technologies. KJA is currently a member of the Australian Parliament, but all work for this Article was undertaken before April 12, 2019, by which time she had resigned from all paid and honorary appointments listed. SLP reports having received honoraria from Swisse Biostime and Personal Lifestyle Medicine Institute. ADG reports having received consultant fees from Aimmune Therapeutics, DBV Technologies, and Nestle (research grant and advisory panel). MLKT declares consultant fees from Pfizer and Abbott Nutrition; inventorship on patents covering PPOIT; employee and scientific founder of, and holds share interest and options in, Prota Therapeutics; membership of the Medical Advisory Board of Anaphylaxis & Anaphylaxis Australia and past membership of the Board of Directors of the World Allergy Organization (WAO, ended 2019); membership of expert committees of the American Academy of Allergy Asthma and Immunology, Asia Pacific Association of Allergy Asthma and Clinical Immunology, Australasian Society of Clinical Immunology and Allergy, WHO, and past membership of the International Union of Immunological Societies (ended 2019). All other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: Bronchiolitis is the most common reason for hospitalisation in infants. All international bronchiolitis guidelines recommend supportive care, yet considerable variation in practice continues with infants receiving non-evidence based therapies. We developed six targeted, theory-informed interventions; clinical leads, stakeholder meeting, train-the-trainer, education delivery, other educational materials, and audit and feedback. A cluster randomised controlled trial (cRCT) found the interventions to be effective in reducing use of five non-evidence based therapies in infants with bronchiolitis. This process evaluation paper aims to determine whether the interventions were implemented as planned (fidelity), explore end-users' perceptions of the interventions and evaluate cRCT outcome data with intervention fidelity data., Methods: A pre-specified mixed-methods process evaluation was conducted alongside the cRCT, guided by frameworks for process evaluation of cRCTs and complex interventions. Quantitative data on the fidelity, dose and reach of interventions were collected from the 13 intervention hospitals during the study and analysed using descriptive statistics. Qualitative data identifying perception and acceptability of interventions were collected from 42 intervention hospital clinical leads on study completion and analysed using thematic analysis., Results: The cRCT found targeted, theory-informed interventions improved bronchiolitis management by 14.1%. The process evaluation data found variability in how the intervention was delivered at the cluster and individual level. Total fidelity scores ranged from 55 to 98% across intervention hospitals (mean = 78%; SD = 13%). Fidelity scores were highest for use of clinical leads (mean = 98%; SD = 7%), and lowest for use of other educational materials (mean = 65%; SD = 19%) and audit and feedback (mean = 65%; SD = 20%). Clinical leads reflected positively about the interventions, with time constraints being the greatest barrier to their use., Conclusion: Our targeted, theory-informed interventions were delivered with moderate fidelity, and were well received by clinical leads. Despite clinical leads experiencing challenges of time constraints, the level of fidelity had a positive effect on successfully de-implementing non-evidence-based care in infants with bronchiolitis. These findings will inform widespread rollout of our bronchiolitis interventions, and guide future practice change in acute care settings., Trial Registration: Australian and New Zealand Clinical Trials Registry: ACTRN12616001567415 ., (© 2021. The Author(s).)

Importance: In developed countries, bronchiolitis is the most common reason for infants to be admitted to the hospital, and all international bronchiolitis guidelines recommend supportive care; however, significant variation in practice continues with infants receiving non-evidence-based therapies. Deimplementation research aims to reduce the use of low-value care, and advancing science in this area is critical to delivering evidence-based care., Objective: To determine the effectiveness of targeted interventions vs passive dissemination of an evidence-based bronchiolitis guideline in improving treatment of infants with bronchiolitis., Design, Setting, and Participants: This international, multicenter cluster randomized clinical trial included 26 hospitals (clusters) in Australia and New Zealand providing tertiary or secondary pediatric care (13 randomized to intervention, 13 to control) during the 2017 bronchiolitis season. Data were collected on 8003 infants for the 3 bronchiolitis seasons (2014-2016) before the implementation period and 3727 infants for the implementation period (2017 bronchiolitis season, May 1-November 30). Data were analyzed from November 16, 2018, to December 9, 2020., Interventions: Interventions were developed using theories of behavior change to target key factors that influence bronchiolitis management. These interventions included site-based clinical leads, stakeholder meetings, a train-the-trainer workshop, targeted educational delivery, other educational and promotional materials, and audit and feedback., Main Outcomes and Measures: The primary outcome was compliance during the first 24 hours of care with no use of chest radiography, albuterol, glucocorticoids, antibiotics, and epinephrine, measured retrospectively from medical records of randomly selected infants with bronchiolitis who presented to the hospital. There were no patient-level exclusions., Results: A total of 26 hospitals were randomized without dropouts. Analysis was by intention to treat. Baseline data collected on 8003 infants for 3 bronchiolitis seasons (2014-2016) before the implementation period were similar between intervention and control hospitals. Implementation period data were collected on 3727 infants, including 2328 boys (62%) and 1399 girls (38%), with a mean (SD) age of 6.0 (3.2) months. A total of 459 (12%) were Māori (New Zealand), and 295 (8%) were Aboriginal/Torres Strait Islander (Australia). Compliance with recommendations was 85.1% (95% CI, 82.6%-89.7%) in intervention hospitals vs 73.0% (95% CI, 65.3%-78.8%) in control hospitals (adjusted risk difference, 14.1%; 95% CI, 6.5%-21.7%; P < .001)., Conclusions and Relevance: Targeted interventions led to improved treatment of infants with bronchiolitis. This study has important implications for bronchiolitis management and the development of effective interventions to deimplement low-value care., Trial Registration: Australian and New Zealand Clinical Trials Registry: ACTRN12616001567415.

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 Lactobacillus rhamnosus CGMCC 1.3724 with peanut oral immunotherapy (OIT) is highly effective at inducing sustained unresponsiveness, with benefit persisting to 4 years after treatment cessation in the majority of initial treatment responders. In this study, we plan to extend the probiotic food OIT platform to another allergen, namely egg. We describe the protocol for a phase 2, dual-centre, randomised, controlled trial evaluating the effectiveness of probiotic and egg OIT at inducing desensitisation or sustained unresponsiveness (remission) in participants with egg allergy compared with placebo., Methods and Analysis: 80 participants aged 5-30 years of age with current egg allergy confirmed by double-blind placebo-controlled food challenge at study screening will be recruited from Australia and Singapore. There are two intervention arms-probiotic and egg OIT (active) or placebo. Interventions are administered once daily for 18 months. The primary outcome is the proportion of participants who attain 8-week sustained unresponsiveness in the active group versus placebo group., Ethics and Dissemination: This study has been approved by the Human Research Ethics Committees at the Royal Children's Hospital (HREC 2019.082) and the National Healthcare Group Domain Specific Review Board (2019/00029). Results will be published in peer-reviewed journals and disseminated via presentations at international conferences., Trial Registration Number: ACTRN12619000480189., Competing Interests: Competing interests: MLKT is a past member of Nestle Nutrition Institute Medical Advisory Board Oceania, past member of Nutricia global scientific advisory board; received speaker fees from Nestle Nutrition Institute and Abbott Nutrition; consultant to Bayer Pharmaceuticals; received research funding from Abbott Nutrition, Bayer Pharmaceuticals, Prota Therapeutics; employee of Prota Therapeutics and inventor on a patent owned by MCRI 'A method for inducing tolerance'. LP-CS has received reimbursement for speaking at conferences sponsored by Danone and Nestle and consulting for Mead Johnson and Nestle. LP-CS has received research funding from Danone. ALL has received funding from Aimmune Therapeutics., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Peanut allergy is the the most common cause of life-threatening food-induced anaphylaxis. There is currently no effective long-term treatment. There is a pressing need for definitive treatments that improve the quality of life and prevent fatalities. Allergen oral immunotherapy (OIT) is a promising approach, which is effective at inducing desensitisation; however, OIT has a limited ability to induce sustained unresponsiveness (SU). We have previously shown that a novel treatment comprising a combination of the probiotic Lactobacillus rhamnosus CGMCC 1.3724 with peanut OIT (Probiotic Peanut Oral ImmunoTherapy (PPOIT)) is highly effective at inducing SU, with benefit persisting to 4 years after treatment cessation in the majority of initial treatment responders. Here we describe the protocol for a Phase IIb multicentre, double-blind, randomised, controlled trial (PPOIT-003) with dual primary objectives to evaluate the effectiveness of PPOIT at inducing SU (assessed at 8 weeks after treatment cessation) compared with placebo treatment and peanut OIT alone, in children with peanut allergy., Methods and Analysis: 200 children 1 to 10 years of age with current peanut allergy confirmed by failed double-blind placebo-controlled food challenge (DBPCFC) at study screening will be recruited from three tertiary paediatric hospitals in Australia. There are three intervention arms-PPOIT, peanut OIT alone or placebo. Interventions are administered once daily for 18 months. The dual primary outcomes are: (1) the proportion of children who attain 8-week SU in the PPOIT group versus placebo group and (2) the proportion of children who attain 8-week SU in the PPOIT group versus OIT group., Ethics and Dissemination: This study has been approved by the Human Research Ethics Committees at the Royal Children's Hospital (HREC 35246) and the Child and Adolescent Health Service (RGS 2543). Results will be published in peer-reviewed journals and disseminated via presentations at international conferences., Trial Registration Number: ACTRN12616000322437., Competing Interests: Competing interests: MT is a past member of Nestle Nutrition Institute Medical Advisory Board Oceania; past member of Nutricia global scientific advisory board; speaker fees from Nestle Nutrition Institute and Abbott Nutrition; consultant to Bayer Pharmaceuticals; research funding from Abbott Nutrition, Bayer Pharmaceuticals, Prota Therapeutics; employee of Prota Therapeutics and inventor on a patent owned by Murdoch Children’s Research Institute ‘A method for inducing tolerance’., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The first years of school are critical in establishing a foundation for positive long-term academic, social and well-being outcomes. Mindfulness-based interventions may help students transition well into school, but few robust studies have been conducted in this age group. We aim to determine whether compared with controls, children who receive a mindfulness intervention within the first years of primary school have better: (1) immediate attention/short-term memory at 18 months post-randomisation (primary outcome); (2) inhibition, working memory and cognitive flexibility at 18 months post-randomisation; (3) socio-emotional well-being, emotion-regulation and mental health-related behaviours at 6 and 18 months post-randomisation; (4) sustained changes in teacher practice and classroom interactions at 18 months post-randomisation. Furthermore, we aim to determine whether the implementation predicts the efficacy of the intervention, and the cost effectiveness relative to outcomes., Methods and Analysis: This cluster randomised controlled trial will be conducted in 22 primary schools in disadvantaged areas of Melbourne, Australia. 826 students in the first year of primary school will be recruited to detect between groups differences of Cohen's d=0.25 at the 18-month follow-up. Parent, teacher and child-assessment measures of child attention, emotion-regulation, executive functioning, socio-emotional well-being, mental health-related behaviour and learning, parent mental well-being, teacher well-being will be collected 6 and 18 months post-randomisation. Implementation factors will be measured throughout the study. Intention-to-treat analyses, accounting for clustering within schools and classes, will adopt a two-level random effects linear regression model to examine outcomes for the intervention versus control students. Unadjusted and analyses adjusted for baseline scores, baseline age, gender and family socioeconomic status will be conducted., Ethics and Dissemination: Ethics approval has been received by the Human Research Ethics Committee at the University of Melbourne. Findings will be reported in peer-review publications, national and international conference presentations and research snapshots directly provided to participating schools and families., Pre-Results Trial Registration Number: Australian New Zealand Clinical Trials Registry (ACTRN12619000326190)., Competing Interests: Competing interests: BD developed the intervention but does not receive any commercial or non-commercial financial entitlements., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Problem: Identifying pregnant women whose children are at risk of poorer development in a rapid, acceptable and feasible way., Background: A range of antenatal psychosocial and socioeconomic risk factors adversely impact children's health, behaviour and cognition., Aim: Investigate whether a brief, waiting room survey of risk factors identifies women experiencing increased antenatal psychosocial and socioeconomic risk when asked in a private, in-home interview., Methods: Brief 10-item survey (including age, social support, health, smoking, stress/anxious mood, education, household income, employment) collected from pregnant women attending 10 Australian public birthing hospitals, used to determine eligibility (at least 2 adverse items) for the "right@home" trial. 735 eligible women completed a private, in-home interview (including mental health, wellbeing, substance use, domestic violence, housing problems). Regression models tested for dose-response trends between the survey risk factor count and interview measures., Findings: 38%, 31%, 15% and 16% of women reported a survey count of 2, 3, 4 and 5 or more adverse risk factors, respectively. Dose-response relationships were evident between the survey count and interview measures, e.g. of women with a survey count of 2, 8% reported ever having a drug problem, 4% experienced domestic violence in the last year and 10% experienced housing problems, contrasting with 31%, 31% and 26%, respectively, for women reporting a survey count of 5 or more., Discussion/conclusions: A brief, waiting room survey of psychosocial and socioeconomic risk factors concurs with a private antenatal risk factor interview, and could help health professionals quickly identify which women would benefit from more support., (Copyright © 2018 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.)

Background: Outpatient parenteral antimicrobial therapy in children is common despite no evidence of its efficacy or safety from clinical trials. We aimed to compare the efficacy and safety of intravenous antibiotic therapy at home with that of standard treatment in hospital for children with moderate to severe cellulitis., Methods: The Cellulitis at Home or Inpatient in Children from the Emergency Department (CHOICE) trial was a randomised, controlled, non-inferiority trial in children aged 6 months to 18 years who presented to the emergency department at The Royal Children's Hospital (Melbourne, VIC, Australia) with uncomplicated moderate to severe cellulitis. Participants were randomly assigned to receive either intravenous ceftriaxone (50 mg/kg once daily) at home or intravenous flucloxacillin (50 mg/kg every 6 h) in hospital with web-based randomisation, stratified by age and periorbital cellulitis. The primary outcome was treatment failure, which was defined as no clinical improvement or occurrence of an adverse event, resulting in a change in empiric antibiotics within 48 h of the first dose. Secondary outcomes included adverse events and acquisition of antibiotic-resistant bacteria. Outcomes were assessed in all randomised participants with outcome data (intention-to-treat population) and in all individuals who received treatment as allocated and did not have any major protocol violations (per-protocol population). For home treatment to be non-inferior to hospital treatment, the difference between groups in the proportion of children with treatment failure in the intention-to-treat population had to be less than 15%. This trial is registered with ClinicalTrials.gov, number NCT02334124., Findings: Between Jan 9, 2015, and June 15, 2017, we screened 1135 children for eligibility, of whom 190 were randomly assigned to receive ceftriaxone at home (n=95) or flucloxacillin in hospital (n=95). The intention-to-treat analysis comprised 188 children (93 in the home group and 95 in the hospital group) because two children in the home group were found to be ineligible after randomisation and were excluded. Treatment failure occurred in two (2%) children in the home group and in seven (7%) children in the hospital group (risk difference -5·2%, 95% CI -11·3 to 0·8, p=0·088). In the per-protocol analysis, treatment failure occurred in one (1%) of 89 children in the home group and in seven (8%) of 91 children in the hospital group (-6·5%, -12·4 to -0·7). Fewer children treated at home than in hospital had an adverse event (two [2%] vs ten [11%]; p=0·048). There was no difference between groups in rates of nasal acquisition of meticillin-resistant Staphylococcus aureus or gastrointestinal acquisition of extended-spectrum β-lactamase-producing bacteria or Clostridium difficile after 3 months., Interpretation: Home treatment with intravenous ceftriaxone is not inferior to treatment in hospital with intravenous flucloxacillin for children with cellulitis. The standard of care for the intravenous treatment of uncomplicated cellulitis in children should be home or outpatient care when feasible., Funding: The Royal Children's Hospital Foundation and Murdoch Children's Research Institute., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background: Bronchiolitis is the most common reason for admission to hospital for infants less than one year of age. Although management is well defined, there is substantial variation in practice, with infants receiving ineffective therapies or management. This study will test the effectiveness of tailored, theory informed knowledge translation (KT) interventions to decrease the use of five clinical therapies or management processes known to be of no benefit, compared to usual dissemination practices in infants with bronchiolitis. The primary objective is to establish whether the KT interventions are effective in increasing compliance to five evidence based recommendations in the first 24 h following presentation to hospital. The five recommendations are that infants do not receive; salbutamol, antibiotics, glucocorticoids, adrenaline, or a chest x-ray., Methods/design: This study is designed as a cluster randomised controlled trial. We will recruit 24 hospitals in Australia and New Zealand, stratified by country and provision of tertiary or secondary paediatric care. Hospitals will be randomised to either control or intervention groups. Control hospitals will receive a copy of the recent Australasian Bronchiolitis Guideline. Intervention hospitals will receive KT interventions informed by a qualitative analysis of factors influencing clinician care of infants with bronchiolitis. Key interventions include, local stakeholder meetings, identifying medical and nursing clinical leads in both emergency departments and paediatric inpatient areas who will attend a single education train-the-trainer day to then deliver standardised staff education with the training materials provided and coordinate audit and feedback reports locally over the study period. Data will be extracted retrospectively for three years prior to the study intervention year, and for seven months of the study intervention year bronchiolitis season following intervention delivery to determine compliance with the five evidence-based recommendations. Data will be collected to assess fidelity to the implementation strategies and to facilitate an economic evaluation., Discussion: This study will contribute to the body of knowledge to determine the effectiveness of tailored, theory informed interventions in acute care paediatric settings, with the aim of reducing the evidence to practice gaps in the care of infants with bronchiolitis., Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616001567415 (retrospectively registered on 14 November 2016).