START CARE: a protocol for a randomised controlled trial of step-wise budesonide-formoterol reliever-based treatment in children.

Background: Asthma is the most common chronic childhood respiratory condition globally. Inhaled corticosteroid (ICS)-formoterol reliever-based regimens reduce the risk of asthma exacerbations compared with conventional short-acting ß2-agonist (SABA) reliever-based regimens in adults and adolescents. The current limited evidence for anti-inflammatory reliever therapy in children means it is unknown whether these findings are also applicable to children. High-quality randomised controlled trials (RCTs) are needed. Objective: The study aim is to determine the efficacy and safety of budesonide-formoterol reliever alone or maintenance and reliever therapy (MART) compared with standard therapy: budesonide or budesonide-formoterol maintenance, both with terbutaline reliever, in children aged 5 to 11 years with mild, moderate and severe asthma. Methods: A 52-week, multicentre, open-label, parallel group, phase III, two-sided superiority RCT will recruit 400 children aged 5 to 11 years with asthma. Participants will be randomised 1:1 to either budesonide-formoterol 100/6 µg Turbuhaler reliever alone or MART; or budesonide or budesonide-formoterol Turbuhaler maintenance, with terbutaline Turbuhaler reliever. The primary outcome is moderate and severe asthma exacerbations as rate per participant per year. Secondary outcomes are asthma control, lung function, exhaled nitric oxide and treatment step change. Assessment of Turbuhaler technique and cost-effectiveness analysis are also planned. Conclusion: This will be the first RCT to compare the efficacy and safety of a step-wise budesonide-formoterol reliever alone or MART regimen with conventional inhaled ICS or ICS-long-acting ß-agonist maintenance plus SABA reliever in children. The results will provide a much-needed evidence base for the treatment of asthma in children.

Status epilepticus in Auckland, New Zealand: Treatment patterns and determinants of outcome in a prospective population-based cohort.

OBJECTIVE: Determination of the real-world performance of a health care system in the treatment of status epilepticus (SE). METHODS: Prospective, multicenter population-based study of SE in Auckland, New Zealand (NZ) over 1 year, with data recorded in the EpiNet database. Focus on treatment patterns and determinants of SE duration and 30-day mortality. The incidence, etiology, ethnic discrepancies, and seizure characteristics of this cohort have been published previously. RESULTS: A total of 365 patients were included in this treatment cohort; 326 patients (89.3%) were brought to hospital because of SE, whereas 39 patients (10.7%) developed SE during a hospital admission for another reason. Overall, 190 (52.1%) had a known history of epilepsy and 254 (70.0%) presented with SE with prominent motor activity. The mean Status Epilepticus Severity Score (STESS) was 2.15 and the mean SE duration of all patients was 44 min. SE self-terminated without any treatment in 84 patients (22.7%). Earlier administration of appropriately dosed benzodiazepine in the pre-hospital setting was a major determinant of SE duration. Univariate analysis demonstrated that mortality was significantly higher in older patients, patients with longer durations of SE, higher STESS, and patients who developed SE in hospital, but these did not maintain significance with multivariate analysis. There was no difference in the performance of the health care system in the treatment of SE across ethnic groups. SIGNIFICANCE: When SE was defined as 10 continuous minutes of seizure, overall mortality was lower than expected and many patients had self-limited presentations for which no treatment was required. Although there were disparities in the incidence of SE across ethnic groups there was no difference in treatment or outcome. The finding highlights the benefit of a health care system designed to deliver universal health care.

Cardiovascular outcomes 50 years after antenatal exposure to betamethasone: Follow-up of a randomised double-blind, placebo-controlled trial.

BACKGROUND: Antenatal corticosteroids for women at risk of preterm birth reduce neonatal morbidity and mortality, but there is limited evidence regarding their effects on long-term health. This study assessed cardiovascular outcomes at 50 years after antenatal exposure to corticosteroids. METHODS AND FINDINGS: We assessed the adult offspring of women who participated in the first randomised, double-blind, placebo-controlled trial of antenatal betamethasone for the prevention of neonatal respiratory distress syndrome (RDS) (1969 to 1974). The first 717 mothers received 2 intramuscular injections of 12 mg betamethasone or placebo 24 h apart and the subsequent 398 received 2 injections of 24 mg betamethasone or equivalent volume of placebo. Follow-up included a health questionnaire and consent to access administrative data sources. The co-primary outcomes were the prevalence of cardiovascular risk factors (any of hypertension, hyperlipidaemia, diabetes mellitus, gestational diabetes mellitus, or prediabetes) and age at first major adverse cardiovascular event (MACE) (cardiovascular death, myocardial infarction, coronary revascularisation, stroke, admission for peripheral vascular disease, and admission for heart failure). Analyses were adjusted for gestational age at entry, sex, and clustering. Of 1,218 infants born to 1,115 mothers, we followed up 424 (46% of survivors; 212 [50%] female) at mean (standard deviation) age 49.3 (1.0) years. There were no differences between those exposed to betamethasone or placebo for cardiovascular risk factors (159/229 [69.4%] versus 131/195 [67.2%]; adjusted relative risk 1.02, 95% confidence interval [CI] [0.89, 1.18;]; p = 0.735) or age at first MACE (adjusted hazard ratio 0.58, 95% CI [0.23, 1.49]; p = 0.261). There were also no differences in the components of these composite outcomes or in any of the other secondary outcomes. Key limitations were follow-up rate and lack of in-person assessments. CONCLUSIONS: There is no evidence that antenatal corticosteroids increase the prevalence of cardiovascular risk factors or incidence of cardiovascular events up to 50 years of age. Established benefits of antenatal corticosteroids are not outweighed by an increase in adult cardiovascular disease.

Appraisal of Australian and New Zealand paediatric sepsis guidelines.

OBJECTIVE: Clinical practice guidelines (CPGs) are an important tool for the management of children with sepsis. The quality, consistency and concordance of Australian and New Zealand (ANZ) childhood sepsis CPGs with the Australian Commission on Safety and Quality in Healthcare (ACSQHC) sepsis clinical care standards and international sepsis guidelines is unclear. METHODS: We accessed childhood sepsis CPGs for all ANZ states and territories through Paediatric Research in Emergency Departments International Collaborative members. The guidelines were assessed for quality using the AGREE-II instrument. Consistency between CPG treatment recommendations was assessed, as was concordance with the ACSQHC sepsis clinical care standards and international sepsis guidelines. RESULTS: Overall, eight CPGs were identified and assessed. CPGs used a narrative and pathway format, with those using both having the highest quality overall. CPG quality was highest for description of scope and clarity of presentation, and lowest for editorial independence. Consistency between guidelines for initial treatment recommendations was poor, with substantial variation in the choice and urgency of empiric antimicrobial administration; the choice, volume and urgency of fluid resuscitation; and the choice of first-line vasoactive agent. Most CPGs were concordant with time-critical components of the ACSQHC sepsis clinical care standard, although few addressed post-acute care. Concordance with international sepsis guidelines was poor. CONCLUSION: Childhood sepsis CPGs in current use in ANZ are of variable quality and lack consistency with key treatment recommendations. CPGs are concordant with the ACSQHC care standard, but not with international sepsis guidelines. A bi-national sepsis CPG may reduce unnecessary variation in care.

Facial Function in Bell Palsy in a Cohort of Children Randomized to Prednisolone or Placebo 12 Months After Diagnosis.

BACKGROUND: Information on the medium-term recovery of children with Bell palsy or acute idiopathic lower motor neuron facial paralysis is limited. METHODS: We followed up children aged 6 months to <18 years with Bell palsy for 12 months after completion of a randomized trial on the use of prednisolone. We assessed facial function using the clinician-administered House-Brackmann scale and the modified parent-administered House-Brackmann scale. RESULTS: One hundred eighty-seven children were randomized to prednisolone (n = 93) or placebo (n = 94). At six months, the proportion of patients who had recovered facial function based on the clinician-administered House-Brackmann scale was 98% (n = 78 of 80) in the prednisolone group and 93% (n = 76 of 82) in the placebo group. The proportion of patients who had recovered facial function based on the modified parent-administered House-Brackmann scale was 94% (n = 75 of 80) vs 89% (n = 72 of 81) at six months (OR 1.88; 95% CI 0.60, 5.86) and 96% (n = 75 of 78) vs 92% (n = 73 of 79) at 12 months (OR 3.12; 95% CI 0.61, 15.98). CONCLUSIONS: Although the vast majority had complete recovery of facial function at six months, there were some children without full recovery of facial function at 12 months, regardless of prednisolone use.

Understanding the uptake and adaption of targeted implementation interventions for reducing bronchiolitis investigations and therapies.

AIM: To understand and evaluate the uptake and local adaptations of proven targeted implementation interventions that have effectively reduced unnecessary investigations and therapies in infants with bronchiolitis within emergency departments. METHODS: A multi-centred, mixed-methods quality improvement study in four Australian hospitals that provide paediatric emergency and inpatient care from May to December 2021. All hospitals were provided with the same implementation intervention package and training. Real-time tracking logs of adaptions were completed followed by semi-structured interviews. Interviews were recorded, transcribed and subsequently coded using FRAME-IS to further describe the adaptions made. RESULTS: Tracking logs were summarised and data from 12 interviews were compared from participating sites. The intervention resulted in 116 education sessions and a total of 23 adaptations made to educational materials, both content and contextual. Shortening education presentations, addition of bronchiolitis definitions, formatting of materials and novel interventions were the most common modifications. Audit and feedback were completed across all sites with varying utilisation. Targeted teaching was noted to dictate adaptions prior to and during implementation. CONCLUSION: Quantitative and qualitative analysis of clinical 'real-world' adaptations to proven targeted implementation interventions allows invaluable insight for future de-implementation initiatives and national roll-out of implementation packages in the ED setting.

Mild Traumatic Brain Injury Characteristics and Symptoms in Preschool Children: How Do They Differ to School Age Children? A Multicenter Prospective Observational Study.

OBJECTIVE: To investigate if preschool children differ to school age children with mild traumatic brain injury (TBI) with respect to injury causes, clinical presentation, and medical management. DESIGN: A secondary analysis of a dataset from a large, prospective and multisite cohort study on TBI in children aged 0-18 years, the Australian Paediatric Head Injury Rules Study. SETTING: Nine pediatric emergency departments (ED) and 1 combined adult and pediatric ED located across Australia and New Zealand. PARTICIPANTS: 7080 preschool aged children (2-5 years) were compared with 5251 school-age children (6-12 years) with mild TBI (N= (N=12,331) MAIN OUTCOME MEASURES: Clinical report form on medical symptoms, injury causes, and management. RESULTS: Preschool children were less likely to be injured with a projectile than school age children (P<.001). Preschool children presented with less: loss of consciousness (P<.001), vomiting (P<.001), drowsiness (P=.002), and headache (P<.001), and more irritability and agitation (P=.003), than school-age children in the acute period after mild TBI. Preschool children were less likely to have neuroimaging of any kind (P<.001) or to be admitted for observation than school age children (P<.001). CONCLUSIONS: Our large prospective study has demonstrated that preschool children with mild TBI experience a different acute symptom profile to older children. There are significant clinical implications with symptoms post-TBI used in medical management to aid decisions on neuroimaging and post-acute intervention.

Pain in children with Bell's palsy: secondary analysis of a randomised controlled trial.

OBJECTIVE: To describe the prevalence and severity of pain experienced by children with Bell's palsy over the first 6 months of illness and its association with the severity of facial paralysis. METHODS: This was a secondary analysis of data obtained in a phase III, triple-blinded, randomised, placebo-controlled trial of prednisolone for the treatment of Bell's palsy in children aged 6 months to <18 years conducted between 13 October 2015 and 23 August 2020 in Australia and New Zealand. Children were recruited within 72 hours of symptom onset and pain was assessed using a child-rated visual analogue scale (VAS), a child-rated Faces Pain Score-Revised (FPS-R) and/or a parent-rated VAS at baseline, and at 1, 3 and 6 months until recovered, and are reported combined across treatment groups. RESULTS: Data were available for 169 of the 187 children randomised from at least one study time point. Overall, 37% (62/169) of children reported any pain at least at one time point. The frequency of any pain reported using the child-rated VAS, child-rated FPS-R and parent-rated VAS was higher at the baseline assessment (30%, 23% and 27%, respectively) compared with 1-month (4%, 0% and 4%, respectively) and subsequent follow-up assessments. At all time points, the median pain score on all three scales was 0 (no pain). CONCLUSIONS: Pain in children with Bell's palsy was infrequent and primarily occurred early in the disease course and in more severe disease. The intensity of pain, if it occurs, is very low throughout the clinical course of disease. TRIAL REGISTRATION NUMBER: ACTRN12615000563561.

Core outcomes and factors influencing the experience of care for children with severe acute exacerbations of asthma: a qualitative study.

OBJECTIVE: To identify the outcomes considered important, and factors influencing the patient experience, for parents and caregivers of children presenting to hospital with a severe acute exacerbation of asthma. This work contributes to the outcome-identification process in developing a core outcome set (COS) for future clinical trials in children with severe acute asthma. DESIGN: A qualitative study involving semistructured interviews with parents and caregivers of children who presented to hospital with a severe acute exacerbation of asthma. SETTING: Hospitals in 12 countries associated with the global Pediatric Emergency Research Networks, including high-income and middle-income countries. Interviews were conducted face-to-face, by teleconference/video-call, or by phone. FINDINGS: Overall, there were 54 interviews with parents and caregivers; 2 interviews also involved the child. Hospital length of stay, intensive care unit or high-dependency unit (HDU) admission, and treatment costs were highlighted as important outcomes influencing the patient and family experience. Other potential clinical trial outcomes included work of breathing, speed of recovery and side effects. In addition, the patient and family experience was impacted by decision-making leading up to seeking hospital care, transit to hospital, waiting times and the use of intravenous treatment. Satisfaction of care was related to communication with clinicians and frequent reassessment. CONCLUSIONS: This study provides insight into the outcomes that parents and caregivers believe to be the most important to be considered in the process of developing a COS for the treatment of acute severe exacerbations of asthma.

Impact of SARS-CoV-2 Infection on the Association Between Laboratory Tests and Severe Outcomes Among Hospitalized Children.

Background: To assist clinicians with identifying children at risk of severe outcomes, we assessed the association between laboratory findings and severe outcomes among severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected children and determined if SARS-CoV-2 test result status modified the associations. Methods: We conducted a cross-sectional analysis of participants tested for SARS-CoV-2 infection in 41 pediatric emergency departments in 10 countries. Participants were hospitalized, had laboratory testing performed, and completed 14-day follow-up. The primary objective was to assess the associations between laboratory findings and severe outcomes. The secondary objective was to determine if the SARS-CoV-2 test result modified the associations. Results: We included 1817 participants; 522 (28.7%) SARS-CoV-2 test-positive and 1295 (71.3%) test-negative. Seventy-five (14.4%) test-positive and 174 (13.4%) test-negative children experienced severe outcomes. In regression analysis, we found that among SARS-CoV-2-positive children, procalcitonin ≥0.5 ng/mL (adjusted odds ratio [aOR], 9.14; 95% CI, 2.90-28.80), ferritin >500 ng/mL (aOR, 7.95; 95% CI, 1.89-33.44), D-dimer ≥1500 ng/mL (aOR, 4.57; 95% CI, 1.12-18.68), serum glucose ≥120 mg/dL (aOR, 2.01; 95% CI, 1.06-3.81), lymphocyte count <1.0 × 109/L (aOR, 3.21; 95% CI, 1.34-7.69), and platelet count <150 × 109/L (aOR, 2.82; 95% CI, 1.31-6.07) were associated with severe outcomes. Evaluation of the interaction term revealed that a positive SARS-CoV-2 result increased the associations with severe outcomes for elevated procalcitonin, C-reactive protein (CRP), D-dimer, and for reduced lymphocyte and platelet counts. Conclusions: Specific laboratory parameters are associated with severe outcomes in SARS-CoV-2-infected children, and elevated serum procalcitonin, CRP, and D-dimer and low absolute lymphocyte and platelet counts were more strongly associated with severe outcomes in children testing positive compared with those testing negative.

Multisystem Inflammatory Syndrome in New Zealand Children.

New Zealand (NZ) initially adopted an elimination approach to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Pre-Omicron variant, the NZ pediatric population was immunologically naïve to SARS-CoV-2. This study, utilizing national data sources, describes the NZ incidence of multisystem inflammatory syndrome in children (MIS-C) following infection with the Omicron variant. MIS-C incidence was 1.03 of 100,000 age-specific population and 0.04 of 1000 recorded SARS-CoV-2 infections.

Factors influencing health professionals' use of high-flow nasal cannula therapy for infants with bronchiolitis - A qualitative study.

Aim: To explore the factors influencing the use of high-flow nasal cannula (HFNC) therapy for infants with bronchiolitis. Design: Qualitative approach using semi-structured interviews. Methods: The semi-structured interviews (face-to-face or virtual) were conducted between September 2020 and February 2021. Deductive content analysis was used to map key influencing factors for use of HFNC therapy to the Theoretical Domains Framework (TDF). Results: Nineteen interviews were undertaken before reaching thematic saturation (7 nurses, 12 doctors) in emergency departments and paediatric wards from four purposively selected hospitals in Australia and New Zealand. Influencing factors were mapped to eight domains in the TDF with 21 themes identified. Main findings included: (1) Health professionals' expectations of HFNC therapy on patient deterioration, work of breathing and oxygenation; (2) Staff emotions relating to concern and anxiety about deterioration and "need to do something"; (3) Social influences from other health professionals and parents and (4) Environmental factors relating to logistics of care and patient transfer considerations. These factors, combined with the ready availability of HFNC equipment and health professionals having the required skills to administer the therapy, contributed to its initiation. Conclusion: Individual/personal and contextual/environmental factors contribute to the use of HFNC therapy for infants with bronchiolitis. It is evident these influences contribute substantially to increased use, despite evidence-based guidelines recommending a more nuanced approach to this therapy. These findings will inform a targeted implementation intervention to promote evidence-based use of HFNC therapy in infants with bronchiolitis.

Cost-effectiveness of Prednisolone to Treat Bell Palsy in Children: An Economic Evaluation Alongside a Randomized Controlled Trial.

BACKGROUND AND OBJECTIVES: Bell palsy is the third most frequent diagnosis in children with sudden-onset neurologic dysfunction. The cost-effectiveness of treating Bell palsy with prednisolone in children is unknown. We aimed to assess the cost-effectiveness of prednisolone in treating Bell palsy in children compared with placebo. METHODS: This economic evaluation was a prospectively planned secondary analysis of a double-blinded, randomized, placebo-controlled superiority trial (Bell Palsy in Children [BellPIC]) conducted from 2015 to 2020. The time horizon was 6 months since randomization. Children aged 6 months to <18 years who presented within 72 hours of onset of clinician-diagnosed Bell palsy and who completed the trial were included (N = 180). Interventions were oral prednisolone or taste-matched placebo administered for 10 days. Incremental cost-effectiveness ratio comparing prednisolone with placebo was estimated. Costs were considered from a health care sector perspective and included Bell palsy-related medication cost, doctor visits, and medical tests. Effectiveness was measured using quality-adjusted life-years (QALYs) based on Child Health Utility 9D. Nonparametric bootstrapping was performed to capture uncertainties. Prespecified subgroup analysis by age 12 to <18 years vs <12 years was conducted. RESULTS: The mean cost per patient was A$760 in the prednisolone group and A$693 in the placebo group over the 6-month period (difference A$66, 95% CI -A$47 to A$179). QALYs over 6 months were 0.45 in the prednisolone group and 0.44 in the placebo group (difference 0.01, 95% CI -0.01 to 0.03). The incremental cost to achieve 1 additional recovery was estimated to be A$1,577 using prednisolone compared with placebo, and cost per additional QALY gained was A$6,625 using prednisolone compared with placebo. Given a conventional willingness-to-pay threshold of A$50,000 per QALY gained (equivalent to US$35,000 or £28,000), prednisolone is very likely cost-effective (probability is 83%). Subgroup analysis suggests that this was primarily driven by the high probability of prednisolone being cost-effective in children aged 12 to <18 years (probability is 98%) and much less so for those <12 years (probability is 51%). DISCUSSION: This provides new evidence to stakeholders and policymakers when considering whether to make prednisolone available in treating Bell palsy in children aged 12 to <18 years. TRIAL REGISTRATION INFORMATION: Australian New Zealand Clinical Trials Registry ACTRN12615000563561.

Evaluation of targeted implementation interventions for reducing investigations and therapies in infants with bronchiolitis.

AIM: To evaluate the impact of locally adapted targeted implementation interventions on bronchiolitis management through reduction in ineffective investigation and therapies within emergency departments. METHODS: A multi-centred, quality improvement study in four different grades of hospitals in Western Australia that provide paediatric emergency and inpatient care. All hospitals incorporated an adapted implementation intervention package for infants under 1 year with bronchiolitis. The proportion whose care complied with guideline recommendations to not receive investigations and therapies of minimal benefit were compared to pre-intervention care in a previous bronchiolitis season. RESULTS: A total of 457 infants in 2019 (pre-intervention) and 443 in 2021 (post-intervention) were included, with mean age of 5.6 months (SD 3.2, 2019; SD 3.0, 2021). In 2019, compliance was 78.1% versus 85.6% in 2021, RD 7.4 (95% CI -0.6; 15.5). The strongest evidence was reduced salbutamol use (compliance improvement: 88.6% to 95.7%, RD 7.1 95% CI (1.7; 12.4)). Hospitals initially at <80% compliance demonstrated greatest improvements (Hospital 2: 95 (78.5%) to 108 (90.8%) RD 12.2 95% CI (3.3; 21.2); Hospital 3: 67 (62.6%) to 63 (76.8%) RD 14.2 95% CI (1.3; 27.2)). CONCLUSION: Targeted site-adapted implementation interventions resulted in improvement in compliance with guideline recommendations, particularly for those hospitals with initial low compliance. Maximising benefits through guidance on how to adapt and effectively use interventions will enhance sustainable practice change.

Agreement Between House-Brackmann and Sunnybrook Facial Nerve Grading Systems in Bell's Palsy in Children: Secondary Analysis of a Randomized, Placebo-Controlled Multicenter Trial.

BACKGROUND: There is limited evidence on the use of facial nerve function grading scales in acute facial nerve paralysis in children. OBJECTIVE: To investigate the agreement between and the usability of the House-Brackmann and Sunnybrook scales in children with idiopathic facial paralysis (Bell's palsy) and to compare their ease of administration. METHODS: Data from a randomized controlled trial in children aged 6 months to <18 years with Bell's palsy was used. Children were recruited within 72 hours of symptom onset and assessed using the House-Brackmann and the Sunnybrook scales at baseline and at 1, 3, and 6 months until recovered. Agreement between the scales was assessed using the intraclass correlation coefficient (ICC) at each time point and using a Bland-Altman plot. Ease of administration was assessed using an 11-point Likert scale. RESULTS: Comparative data were available for 169 of the 187 children randomized. The ICC between the 2 scales across all time points was 0.92 (95% confidence interval [CI] 0.91-0.93), at baseline 0.37 (95% 0.25, 0.51), at 1 month 0.91 (95% CI 0.89-0.94), at 3 months 0.85 (95% CI 0.80-0.89), and at 6 months 0.96 (95% CI 0.95-0.97). The median score for the ease of administration for the House-Brackmann and Sunnybrook scales was 3 (interquartile range [IQR]: 1-5) and 7 (IQR: 4-8) respectively (P < .001, Wilcoxon signed-rank test). CONCLUSIONS: There was excellent agreement between House-Brackmann and Sunnybrook scales, with poorer agreement at baseline. Clinicians found the House-Brackmann scale easier to administer. These findings suggest that both scales can be applied in children.

Effect of Early High-Flow Nasal Oxygen vs Standard Oxygen Therapy on Length of Hospital Stay in Hospitalized Children With Acute Hypoxemic Respiratory Failure: The PARIS-2 Randomized Clinical Trial.

Importance: Nasal high-flow oxygen therapy in infants with bronchiolitis and hypoxia has been shown to reduce the requirement to escalate care. The efficacy of high-flow oxygen therapy in children aged 1 to 4 years with acute hypoxemic respiratory failure without bronchiolitis is unknown. Objective: To determine the effect of early high-flow oxygen therapy vs standard oxygen therapy in children with acute hypoxemic respiratory failure. Design, Setting, and Participants: A multicenter, randomized clinical trial was conducted at 14 metropolitan and tertiary hospitals in Australia and New Zealand, including 1567 children aged 1 to 4 years (randomized between December 18, 2017, and March 18, 2020) requiring hospital admission for acute hypoxemic respiratory failure. The last participant follow-up was completed on March 22, 2020. Interventions: Enrolled children were randomly allocated 1:1 to high-flow oxygen therapy (n = 753) or standard oxygen therapy (n = 764). The type of oxygen therapy could not be masked, but the investigators remained blinded until the outcome data were locked. Main Outcomes and Measures: The primary outcome was length of hospital stay with the hypothesis that high-flow oxygen therapy reduces length of stay. There were 9 secondary outcomes, including length of oxygen therapy and admission to the intensive care unit. Children were analyzed according to their randomization group. Results: Of the 1567 children who were randomized, 1517 (97%) were included in the primary analysis (median age, 1.9 years [IQR, 1.4-3.0 years]; 732 [46.7%] were female) and all children completed the trial. The length of hospital stay was significantly longer in the high-flow oxygen group with a median of 1.77 days (IQR, 1.03-2.80 days) vs 1.50 days (IQR, 0.85-2.44 days) in the standard oxygen group (adjusted hazard ratio, 0.83 [95% CI, 0.75-0.92]; P < .001). Of the 9 prespecified secondary outcomes, 4 showed no significant difference. The median length of oxygen therapy was 1.07 days (IQR, 0.50-2.06 days) in the high-flow oxygen group vs 0.75 days (IQR, 0.35-1.61 days) in the standard oxygen therapy group (adjusted hazard ratio, 0.78 [95% CI, 0.70-0.86]). In the high-flow oxygen group, there were 94 admissions (12.5%) to the intensive care unit compared with 53 admissions (6.9%) in the standard oxygen group (adjusted odds ratio, 1.93 [95% CI, 1.35-2.75]). There was only 1 death and it occurred in the high-flow oxygen group. Conclusions and Relevance: Nasal high-flow oxygen used as the initial primary therapy in children aged 1 to 4 years with acute hypoxemic respiratory failure did not significantly reduce the length of hospital stay compared with standard oxygen therapy. Trial Registration: anzctr.org.au Identifier: ACTRN12618000210279.

Incidence of traumatic brain injuries in head-injured children with seizures.

OBJECTIVE: Incidence and short-term outcomes of clinically important traumatic brain injury (ciTBI) in head-injured children presenting to ED with post-traumatic seizure (PTS) is not described in current literature. METHODS: Planned secondary analysis of a prospective observational study undertaken in 10 Australasian Paediatric Research in Emergency Departments International Collaborative (PREDICT) network EDs between 2011 and 2014 of head-injured children <18 years with and without PTS. Clinical predictors and outcomes were analysed by attributable risk (AR), risk ratios (RR) and 95% confidence interval (CI), including the association with Glasgow Coma Scale (GCS) scores. RESULTS: Of 20 137 head injuries, 336 (1.7%) had PTS with median age of 4.8 years. Initial GCS was 15 in 268/336 (79.8%, AR -16.1 [95% CI -20.4 to -11.8]), 14 in 24/336 (7.1%, AR 4.4 [95% CI 1.6-7.2]) and ≤13 in 44/336 (13.1%, AR 11.7 [95% CI 8.1-15.3]) in comparison with those without PTS, respectively. The ciTBI rate was 34 (10.1%) with PTS versus 219 (1.1%) without PTS (AR 9.0 [95% CI 5.8-12.2]) with 5/268 (1.9%), 6/24 (25.0%) and 23/44 (52.3%) with GCS 15, 14 and ≤13, respectively. In PTS, rates of admission ≥2 nights (34 [10.1%] AR 9.0 [95% CI 5.8-12.3]), intubation >24 h (9 [2.7%] AR 2.5 [95% CI 0.8-4.2]) and neurosurgery (8 [2.4%] AR 2.0 [95% CI 0.4-3.7]), were higher than those without PTS. Children with PTS and GCS 15 or 14 had no neurosurgery, intubations or death, with two deaths in children with PTS and GCS ≤13. CONCLUSIONS: PTS was uncommon in head-injured children presenting to the ED but associated with an increased risk of ciTBI in those with reduced GCS on arrival.