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  • 1
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    Comparing ivWatch biosensor to standard care to identify extravasation injuries in the paediatric intensive care: a protocol for a randomised controlled trial
    BMJ ; 2022
    In:  BMJ Open Vol. 12, No. 2 ( 2022-02), p. e047765-
    Details
    In: BMJ Open, BMJ, Vol. 12, No. 2 ( 2022-02), p. e047765-
    Abstract: Peripheral intravenous catheters (PIVCs) frequently fail during therapy administration, resulting in infusates pooling in the surrounding tissue. These extravasation injuries can cause significant pain, tissue destruction and scarring. ivWatch is a biosensor that uses visible and near-infrared light to measure tissue changes surrounding the PIVC and alert clinicians when extravasation may occur. The effectiveness of ivWatch, in comparison to clinical observation, in decreasing injury severity is unknown. The present study aims to investigate whether using ivWatch may potentially detect injury earlier and decrease the severity of PIVC extravasation injuries. Methods and analysis A single centre, parallel group, open-label superiority randomised controlled trial comparing (a) standard care (clinical observation) to (b) ivWatch monitoring in addition to standard care, to decrease the severity of extravasation injuries. 200 children with PIVCs inserted in the distal half of the limb, receiving intermediate-risk to high-risk infusates for ≥24 hours, will be consecutively recruited at a paediatric intensive care unit in Queensland, Australia. The primary outcome is extravasation severity, measured by the Cincinnati Children’s Extravasation Harm Scale. Secondary outcomes include severity assessed with three-dimensional camera imaging, extravasation volume, treatment sequelae, the number of PIVCs used and dwell time, quality of life and healthcare costs. The between treatment difference in extravasation severity will be compared using ordinal logistic regression, with the treatment group included as the main effect, and reported with corresponding 95% CIs. Estimates of value will be presented as net monetary benefits and cost per reduction in extravasation injury severity, both presented with corresponding 95% credible intervals. Ethics and dissemination This study received approval from the Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC) (reference number: HREC/20/QCHQ/60867) and the Griffith University HREC (reference number: 2020/310) and will be disseminated via peer-reviewed publications and conference presentations. Trial registration number ACTRN12620000317998.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2020-047765
    Language: English
    Publisher: BMJ
    Publication Date: 2022
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  • 2
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    Effectiveness–implementation hybrid-2 randomised trial of a collaborative Shared Care Model for Detecting Neurodevelopmental Impairments after Critical Illness in Young Children (DAISY): pilot study protocol
    BMJ ; 2022
    In:  BMJ Open Vol. 12, No. 7 ( 2022-07), p. e060714-
    Details
    In: BMJ Open, BMJ, Vol. 12, No. 7 ( 2022-07), p. e060714-
    Abstract: In Australia, while paediatric intensive care unit (PICU) mortality has dropped to 2.2%, one in three survivors experience long-term neurodevelopmental impairment, limiting their life-course opportunities. Unlike other high-risk paediatric populations, standardised routine neurodevelopmental follow-up of PICU survivors is rare, and there is limited knowledge regarding the best methods. The present study intends to pilot a combined multidisciplinary, online screening platform and general practitioner (GP) shared care neurodevelopmental follow-up model to determine feasibility of a larger, future study. We will also assess the difference between neurodevelopmental vulnerability and parental stress in two intervention groups and the impact of child, parent, sociodemographic and illness/treatment risk factors on child and parent outcomes. Methods and analysis Single-centre randomised effectiveness–implementation (hybrid-2 design) pilot trial for parents of children aged ≥2 months and 〈 4 years discharged from PICU after critical illness or injury. One intervention group will receive 6 months of collaborative shared care follow-up with GPs (supported by online outcome monitoring), and the other will be offered self-directed screening and education about post-intensive care syndrome and child development. Participants will be followed up at 1, 3 and 6 months post-PICU discharge. The primary outcome is feasibility. Secondary outcomes include neurodevelopmental vulnerability and parental stress. An implementation evaluation will analyse barriers to and facilitators of the intervention. Ethics and dissemination The study is expected to lead to a full trial, which will provide much-needed guidance about the clinical effectiveness and implementation of follow-up models of care for children after critical illness or injury. The Children’s Health Queensland Human Research Ethics Committee approved this study. Dissemination of the outcomes of the study is expected via publication in a peer-reviewed journal, presentation at relevant conferences, and via social media, podcast presentations and open-access medical education resources. Registration details The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry as ‘Pilot testing of a collaborative Shared Care Model for Detecting Neurodevelopmental Impairments after Critical Illness in Young Children’ (the DAISY Pilot Study). Trial registration number ACTRN12621000799853.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2021-060714
    Language: English
    Publisher: BMJ
    Publication Date: 2022
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  • 3
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    Longitudinal cohort study investigating neurodevelopmental and socioemotional outcomes in school-entry aged children after open heart surgery in Australia and New Zealand: the NITRIC follow-up study protocol
    BMJ ; 2023
    In:  BMJ Open Vol. 13, No. 8 ( 2023-08), p. e075429-
    Details
    In: BMJ Open, BMJ, Vol. 13, No. 8 ( 2023-08), p. e075429-
    Abstract: Despite growing awareness of neurodevelopmental impairments in children with congenital heart disease (CHD), there is a lack of large, longitudinal, population-based cohorts. Little is known about the contemporary neurodevelopmental profile and the emergence of specific impairments in children with CHD entering school. The performance of standardised screening tools to predict neurodevelopmental outcomes at school age in this high-risk population remains poorly understood. The NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) trial randomised 1371 children 〈 2 years of age, investigating the effect of gaseous nitric oxide applied into the cardiopulmonary bypass oxygenator during heart surgery. The NITRIC follow-up study will follow this cohort annually until 5 years of age to assess outcomes related to cognition and socioemotional behaviour at school entry, identify risk factors for adverse outcomes and evaluate the performance of screening tools. Methods and analysis Approximately 1150 children from the NITRIC trial across five sites in Australia and New Zealand will be eligible. Follow-up assessments will occur in two stages: (1) annual online screening of global neurodevelopment, socioemotional and executive functioning, health-related quality of life and parenting stress at ages 2–5 years; and (2) face-to-face assessment at age 5 years assessing intellectual ability, attention, memory and processing speed; fine motor skills; language and communication; and socioemotional outcomes. Cognitive and socioemotional outcomes and trajectories of neurodevelopment will be described and demographic, clinical, genetic and environmental predictors of these outcomes will be explored. Ethics and dissemination Ethical approval has been obtained from the Children’s Health Queensland (HREC/20/QCHQ/70626) and New Zealand Health and Disability (21/NTA/83) Research Ethics Committees. The findings will inform the development of clinical decision tools and improve preventative and intervention strategies in children with CHD. Dissemination of the outcomes of the study is expected via publications in peer-reviewed journals, presentation at conferences, via social media, podcast presentations and medical education resources, and through CHD family partners. Trial registration number The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry as ‘Gene Expression to Predict Long-Term Neurodevelopmental Outcome in Infants from the NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) Study – A Multicentre Prospective Trial’. Trial registration: ACTRN12621000904875.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2023-075429
    DOI: 10.1136/bmjopen-2023-075429.supp1
    Language: English
    Publisher: BMJ
    Publication Date: 2023
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  • 4
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    Performance of seven different paediatric early warning scores to predict critical care admission in febrile children presenting to the emergency department: a retrospective cohort study
    BMJ ; 2021
    In:  BMJ Open Vol. 11, No. 5 ( 2021-05), p. e044091-
    Details
    In: BMJ Open, BMJ, Vol. 11, No. 5 ( 2021-05), p. e044091-
    Abstract: Paediatric Early Warning Scores (PEWS) are widely used in the UK, but the heterogeneity across tools and the limited data on their predictive performance represent obstacles to improving best practice. The standardisation of practice through the proposed National PEWS will rely on robust validation. Therefore, we compared the performance of the National PEWS with six other PEWS currently used in NHS hospitals, for their ability to predict critical care (CC) admission in febrile children attending the emergency department (ED). Design Retrospective single-centre cohort study. Setting Tertiary hospital paediatric ED. Participants A total of 11 449 eligible febrile ED attendances were identified from the electronic patient record over a 2-year period. Seven PEWS scores were calculated (Alder Hey, Bedside, Bristol, National, Newcastle and Scotland PEWS, and the Paediatric Observation Priority Score, using the worst observations recorded during their ED stay. Outcomes The primary outcome was CC admission within 48 hours, the secondary outcomes were hospital length of stay (LOS) 〉 48 hours and sepsis-related mortality. Results Of 11 449 febrile children, 134 (1.2%) were admitted to CC within 48 hours of ED presentation, 606 (5.3%) had a hospital LOS 〉 48 hours. 10 (0.09%) children died, 5 (0.04%) were sepsis-related. All seven PEWS demonstrated excellent discrimination for CC admission (range area under the receiver operating characteristic curves (AUC) 0.91–0.95) and sepsis-related mortality (range AUC 0.95–0.99), most demonstrated moderate discrimination for hospital LOS (range AUC 0.69–0.75). In CC admission threshold analyses, bedside PEWS (AUC 0.90; 95% CI 0.86 to 0.93) and National PEWS (AUC 0.90; 0.87–0.93) were the most discriminative, both at a threshold of ≥6. Conclusions Our results support the use of the proposed National PEWS in the paediatric ED for the recognition of suspected sepsis to improve outcomes, but further validation is required in other settings and presentations.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2020-044091
    Language: English
    Publisher: BMJ
    Publication Date: 2021
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  • 5
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    Study protocol: NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC trial): a randomised controlled trial
    BMJ ; 2019
    In:  BMJ Open Vol. 9, No. 8 ( 2019-08), p. e026664-
    Details
    In: BMJ Open, BMJ, Vol. 9, No. 8 ( 2019-08), p. e026664-
    Abstract: Congenital heart disease (CHD) is a major cause of infant mortality. Many infants with CHD require corrective surgery with most operations requiring cardiopulmonary bypass (CPB). CPB triggers a systemic inflammatory response which is associated with low cardiac output syndrome (LCOS), postoperative morbidity and mortality. Delivery of nitric oxide (NO) into CPB circuits can provide myocardial protection and reduce bypass-induced inflammation, leading to less LCOS and improved recovery. We hypothesised that using NO during CPB increases ventilator-free days (VFD) (the number of days patients spend alive and free from invasive mechanical ventilation up until day 28) compared with standard care. Here, we describe the NITRIC trial protocol. Methods and analysis The NITRIC trial is a randomised, double-blind, controlled, parallel-group, two-sided superiority trial to be conducted in six paediatric cardiac surgical centres. One thousand three-hundred and twenty infants 〈 2 years of age undergoing cardiac surgery with CPB will be randomly assigned to NO at 20 ppm administered into the CPB oxygenator for the duration of CPB or standard care (no NO) in a 1:1 ratio with stratification by age ( 〈 6 and ≥6 weeks), single ventricle physiology (Y/N) and study centre. The primary outcome will be VFD to day 28. Secondary outcomes include a composite of LCOS, need for extracorporeal membrane oxygenation or death within 28 days of surgery; length of stay in intensive care and in hospital; and, healthcare costs. Analyses will be conducted on an intention-to-treat basis. Preplanned secondary analyses will investigate the impact of NO on host inflammatory profiles postsurgery. Ethics and dissemination The study has ethical approval (HREC/17/QRCH/43, dated 26 April 2017), is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12617000821392) and commenced recruitment in July 2017. The primary manuscript will be submitted for publication in a peer-reviewed journal. Trial registration number ACTRN12617000821392
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2018-026664
    Language: English
    Publisher: BMJ
    Publication Date: 2019
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  • 6
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    Multicentre, randomised trial to investigate early nasal high—flow therapy in paediatric acute hypoxaemic respiratory failure: a protocol for a randomised controlled trial—a Paediatric Acute respiratory Intervention Study (PARIS 2)
    BMJ ; 2019
    In:  BMJ Open Vol. 9, No. 12 ( 2019-12), p. e030516-
    Details
    In: BMJ Open, BMJ, Vol. 9, No. 12 ( 2019-12), p. e030516-
    Abstract: Acute hypoxaemic respiratory failure (AHRF) in children is the most frequent reason for non-elective hospital admission. During the initial phase, AHRF is a clinical syndrome defined for the purpose of this study by an oxygen requirement and caused by pneumonia, lower respiratory tract infections, asthma or bronchiolitis. Up to 20% of these children with AHRF can rapidly deteriorate requiring non-invasive or invasive ventilation. Nasal high-flow (NHF) therapy has been used by clinicians for oxygen therapy outside intensive care settings to prevent escalation of care. A recent randomised trial in infants with bronchiolitis has shown that NHF therapy reduces the need to escalate therapy. No similar data is available in the older children presenting with AHRF. In this study we aim to investigate in children aged 1 to 4 years presenting with AHRF if early NHF therapy compared with standard-oxygen therapy reduces hospital length of stay and if this is cost-effective compared with standard treatment. Methods and analysis The study design is an open-labelled randomised multicentre trial comparing early NHF and standard-oxygen therapy and will be stratified by sites and into obstructive and non-obstructive groups. Children aged 1 to 4 years (n=1512) presenting with AHRF to one of the participating emergency departments will be randomly allocated to NHF or standard-oxygen therapy once the eligibility criteria have been met (oxygen requirement with transcutaneous saturation 〈 92%/90% (dependant on hospital standard threshold), diagnosis of AHRF, admission to hospital and tachypnoea ≥35 breaths/min). Children in the standard-oxygen group can receive rescue NHF therapy if escalation is required. The primary outcome is hospital length of stay. Secondary outcomes will include length of oxygen therapy, proportion of intensive care admissions, healthcare resource utilisation and associated costs. Analyses will be conducted on an intention-to-treat basis. Ethics and dissemination Ethics approval has been obtained in Australia (HREC/15/QRCH/159) and New Zealand (HDEC 17/NTA/135). The trial commenced recruitment in December 2017. The study findings will be submitted for publication in a peer-reviewed journal and presented at relevant conferences. Authorship of all publications will be decided by mutual consensus of the research team. Trial registration number ACTRN12618000210279
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2019-030516
    Language: English
    Publisher: BMJ
    Publication Date: 2019
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  • 7
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    Validation of a paediatric sepsis screening tool to identify children with sepsis in the emergency department: a statewide prospective cohort study in Queensland, Australia
    BMJ ; 2023
    In:  BMJ Open Vol. 13, No. 1 ( 2023-01), p. e061431-
    Details
    In: BMJ Open, BMJ, Vol. 13, No. 1 ( 2023-01), p. e061431-
    Abstract: The Surviving Sepsis Campaign guidelines recommend the implementation of systematic screening for sepsis. We aimed to validate a paediatric sepsis screening tool and derive a simplified screening tool. Design Prospective multicentre study conducted between August 2018 and December 2019. We assessed the performance of the paediatric sepsis screening tool using stepwise multiple logistic regression analyses with 10-fold cross-validation and evaluated the final model at defined risk thresholds. Setting Twelve emergency departments (EDs) in Queensland, Australia. Participants 3473 children screened for sepsis, of which 523 (15.1%) were diagnosed with sepsis. Interventions A 32-item paediatric sepsis screening tool including rapidly available information from triage, risk factors and targeted physical examination. Primary outcome measure Senior medical officer-diagnosed sepsis combined with the administration of intravenous antibiotics in the ED. Results The 32-item paediatric sepsis screening tool had good predictive performance (area under the receiver operating characteristic curve (AUC) 0.80, 95% CI 0.78 to 0.82). A simplified tool containing 16 of 32 criteria had comparable performance and retained an AUC of 0.80 (95% CI 0.78 to 0.82). To reach a sensitivity of 90% (95% CI 87% to 92%), the final model achieved a specificity of 51% (95% CI 49% to 53%). Sensitivity analyses using the outcomes of sepsis-associated organ dysfunction (AUC 0.84, 95% CI 0.81 to 0.87) and septic shock (AUC 0.84, 95% CI 0.81 to 0.88) confirmed the main results. Conclusions A simplified paediatric sepsis screening tool performed well to identify children with sepsis in the ED. Implementation of sepsis screening tools may improve the timely recognition and treatment of sepsis.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2022-061431
    DOI: 10.1136/bmjopen-2022-061431.supp1
    Language: English
    Publisher: BMJ
    Publication Date: 2023
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  • 8
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    Parental and healthcare professional concern in the diagnosis of paediatric sepsis: a protocol for a prospective multicentre observational study
    BMJ ; 2021
    In:  BMJ Open Vol. 11, No. 9 ( 2021-09), p. e045910-
    Details
    In: BMJ Open, BMJ, Vol. 11, No. 9 ( 2021-09), p. e045910-
    Abstract: Paediatric sepsis is a major contributor to morbidity and mortality worldwide. Assessing concern from parents and healthcare professionals to determine disease severity in a child evaluated for sepsis remains a field requiring further investigation. This study aims to determine the diagnostic accuracy of parental and healthcare professional concern in the diagnosis of children evaluated for sepsis. Methods and analysis This prospective multicentre observational study will be conducted over a 24-month period in the paediatric emergency department (ED) at two tertiary Australian hospitals. A cross-sectional survey design will be used to assess the level of concern in parents, nurses and doctors for children presenting to ED and undergoing assessment for sepsis. The primary outcome is a diagnosis of sepsis, defined as suspected infection plus organ dysfunction at time of survey completion. Secondary outcomes include suspected or proven infection and development of organ dysfunction, defined as a Paediatric Sequential Organ Failure Assessment Score 〉 0, within 48 hours of presentation, paediatric intensive care unit admission, confirmed or probable bacterial infection independent of organ dysfunction, and hospital length of stay. Ethics and dissemination Ethics approval was obtained from Children’s Health Queensland’s Human Research Ethics Committee (HREC/17/QRCH/85). Findings will be shared with relevant stakeholders and disseminated via conferences and peer-reviewed journals Trial registration number WHO Universal Trial Number, U1111-1256-4537; ANZCTR number, ACTRN1262000134092.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2020-045910
    Language: English
    Publisher: BMJ
    Publication Date: 2021
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  • 9
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    Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a protocol for a randomised controlled trial
    BMJ ; 2019
    In:  BMJ Open Vol. 9, No. 2 ( 2019-02), p. e025997-
    Details
    In: BMJ Open, BMJ, Vol. 9, No. 2 ( 2019-02), p. e025997-
    Abstract: Emergency intubation of children with abnormal respiratory or cardiac physiology is a high-risk procedure and associated with a high incidence of adverse events including hypoxemia. Successful emergency intubation is dependent on inter-related patient and operator factors. Preoxygenation has been used to maximise oxygen reserves in the patient and to prolong the safe apnoeic time during the intubation phase. Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) prolongs the safe apnoeic window for a safe intubation during elective intubation. We designed a clinical trial to test the hypothesis that THRIVE reduces the frequency of adverse and hypoxemic events during emergency intubation in children and to test the hypothesis that this treatment is cost-effective compared with standard care. Methods and analysis The Kids THRIVE trial is a multicentre randomised controlled trial performed in participating emergency departments and paediatric intensive care units. 960 infants and children aged 0–16 years requiring emergency intubation for all reasons will be enrolled and allocated to THRIVE or control in a 1:1 allocation with stratification by site, age ( 〈 1, 1–7 and 〉 7 years) and operator (junior and senior). Children allocated to THRIVE will receive weight appropriate transnasal flow rates with 100% oxygen, whereas children in the control arm will not receive any transnasal oxygen insufflation. The primary outcomes are defined as follows: (1) hypoxemic event during the intubation phase defined as SpO 2 〈 90% (patient-dependent variable) and (2) first intubation attempt success without hypoxemia (operator-dependent variable). Analyses will be conducted on an intention-to-treat basis. Ethics and dissemination Ethics approval for the protocol and consent process has been obtained (HREC/16/QRCH/81). The trial has been actively recruiting since May 2017. The study findings will be submitted for publication in a peer-reviewed journal. Trial registration number ACTRN12617000147381.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2018-025997
    Language: English
    Publisher: BMJ
    Publication Date: 2019
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  • 10
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    First-line oxygen therapy with high-flow in bronchiolitis is not cost saving for the health service
    BMJ ; 2020
    In:  Archives of Disease in Childhood Vol. 105, No. 10 ( 2020-10), p. 975-980
    Details
    In: Archives of Disease in Childhood, BMJ, Vol. 105, No. 10 ( 2020-10), p. 975-980
    Abstract: Bronchiolitis is the most common reason for hospital admission in infants. High-flow oxygen therapy has emerged as a new treatment; however, the cost-effectiveness of using it as first-line therapy is unknown. Objective To compare the cost of providing high-flow therapy as a first-line therapy compared with rescue therapy after failure of standard oxygen in the management of bronchiolitis. Methods A within-trial economic evaluation from the health service perspective using data from a multicentre randomised controlled trial for hypoxic infants (≤12 months) admitted to hospital with bronchiolitis in Australia and New Zealand. Intervention costs, length of hospital and intensive care stay and associated costs were compared for infants who received first-line treatment with high-flow therapy (early high-flow, n=739) or for infants who received standard oxygen and optional rescue high-flow (rescue high-flow, n=733). Costs were applied using Australian costing sources and are reported in 2016–2017 AU$. Results The incremental cost to avoid one treatment failure was AU$1778 (95% credible interval (CrI) 207 to 7096). Mean cost of bronchiolitis treatment including intervention costs and costs associated with length of stay was AU$420 (95% CrI −176 to 1002) higher per infant in the early high-flow group compared with the rescue high-flow group. There was an 8% (95% CrI 7.5 to 8.6) likelihood of the early high-flow oxygen therapy being cost saving. Conclusions The use of high-flow oxygen as initial therapy for respiratory failure in infants with bronchiolitis is unlikely to be cost saving to the health system, compared with standard oxygen therapy with rescue high-flow.
    Type of Medium: Online Resource
    ISSN: 0003-9888 , 1468-2044
    URL: Article
    DOI: 10.1136/archdischild-2019-318427
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 1481191-1
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