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https://dora.health.qld.gov.au/qldresearchjspui/handle/1/9
2024-03-29T06:45:56ZMulticentre, 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)
https://dora.health.qld.gov.au/qldresearchjspui/handle/1/1761
Title: 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)
Authors: Franklin, Donna; Schlapbach, Luregn J; Shellshear, Deborah; Babl, Franz E; Oakley, Ed; Borland, Meredith L; Hoeppner, Tobias; George, Shane; Craig, Simon; Neutze, Jocelyn; Williams, Amanda; Acworth, Jason; Schibler, Andreas
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. 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 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. ACTRN12618000210279.2019-01-01T00:00:00ZViscoelastic haemostatic assays and fibrinogen in paediatric acute traumatic coagulopathy: A comprehensive review
https://dora.health.qld.gov.au/qldresearchjspui/handle/1/1760
Title: Viscoelastic haemostatic assays and fibrinogen in paediatric acute traumatic coagulopathy: A comprehensive review
Authors: Maconachie, Sharon; Jansen, Melanie; Cottle, Emma; Roy, John; Ross, Bryony; Winearls, James; George, Shane
Abstract: Haemorrhage in paediatric trauma remains a significant cause of morbidity and mortality. Over recent years there has been increasing attention to the role of fibrinogen in traumatic haemorrhage and the association of low fibrinogen levels with poor patient outcomes. In addition, there has been a move towards using viscoelastic haemostatic assays (VHAs) to rapidly assess coagulation status and guide clinicians in the replacement of coagulation factors, including fibrinogen. In the paediatric population, there has been limited uptake of these principles and a paucity of data to support a change in practice. This paper summarises the available evidence in the published literature through a systematic review, presented in narrative format. There is limited high-quality prospective data on the use of VHA in the management of acute traumatic coagulopathy in the paediatric population. While the use of fibrinogen early in major haemorrhage is becoming standard practice, there are currently no randomised prospective studies comparing fibrinogen concentrate to cryoprecipitate. The early identification of hypo-fibrinogenemia and acute traumatic coagulopathy in paediatric trauma using VHA testing and subsequent early fibrinogen replacement with a concentrated off the shelf product is an attractive treatment option. However, there is currently insufficient high-level evidence to support the use of fibrinogen concentrate over cryoprecipitate in the paediatric trauma population. Pilot studies currently under way will go some way to addressing this important knowledge gap, and facilitate the design of larger definitive multi-centre randomised trials.2020-04-01T00:00:00ZResuscitation in Paediatric Sepsis Using Metabolic Resuscitation-A Randomized Controlled Pilot Study in the Paediatric Intensive Care Unit (RESPOND PICU): Study Protocol and Analysis Plan
https://dora.health.qld.gov.au/qldresearchjspui/handle/1/1759
Title: Resuscitation in Paediatric Sepsis Using Metabolic Resuscitation-A Randomized Controlled Pilot Study in the Paediatric Intensive Care Unit (RESPOND PICU): Study Protocol and Analysis Plan
Authors: Schlapbach, Luregn J; Gibbons, Kristen; Ridolfi, Roberta; Harley, Amanda; Cree, Michele; Long, Debbie; Buckley, David; Erickson, Simon; Festa, Marino; George, Shane; King, Megan; Singh, Puneet; Raman, Sainath; Bellomo, Rinaldo
Abstract: Introduction: Septic shock remains amongst the leading causes of childhood mortality. Therapeutic options to support children with septic shock refractory to initial resuscitation with fluids and inotropes are limited. Recently, the combination of intravenous hydrocortisone with high dose ascorbic acid and thiamine (HAT therapy), postulated to reduce sepsis-related organ dysfunction, has been proposed as a safe approach with potential for mortality benefit, but randomized trials in paediatric patients are lacking. We hypothesize that protocolised early use of HAT therapy ("metabolic resuscitation") in children with septic shock is feasible and will lead to earlier resolution of organ dysfunction. Here, we describe the protocol of the Resuscitation in Paediatric Sepsis Using Metabolic Resuscitation-A Randomized Controlled Pilot Study in the Paediatric Intensive Care Unit (RESPOND PICU). Methods and Analysis: The RESPOND PICU study is an open label randomized-controlled, two-sided multicentre pilot study conducted in paediatric intensive care units (PICUs) in Australia and New Zealand. Sixty children aged between 28 days and 18 years treated with inotropes for presumed septic shock will be randomized in a 1:1 ratio to either metabolic resuscitation (1 mg/kg hydrocortisone q6h, 30 mg/kg ascorbic acid q6h, 4 mg/kg thiamine q12h) or standard septic shock management. Main outcomes include feasibility of the study protocol and survival free of organ dysfunction censored at 28 days. The study cohort will be followed up at 28-days and 6-months post enrolment to assess neurodevelopment, quality of life and functional status. Biobanking will allow ancillary studies on sepsis biomarkers. Ethics and Dissemination: The study received ethical clearance from Children's Health Queensland Human Research Ethics Committee (HREC/18/QCHQ/49168) and commenced enrolment on June 12th, 2019. The primary study findings will be submitted for publication in a peer-reviewed journal. Trial Registration: Australian and New Zealand Clinical Trials Registry (ACTRN12619000829112). Protocol Version: V1.8 22/7/20.2021-04-30T00:00:00ZEarly Resuscitation in Paediatric Sepsis Using Inotropes - A Randomised Controlled Pilot Study in the Emergency Department (RESPOND ED): Study Protocol and Analysis Plan
https://dora.health.qld.gov.au/qldresearchjspui/handle/1/1758
Title: Early Resuscitation in Paediatric Sepsis Using Inotropes - A Randomised Controlled Pilot Study in the Emergency Department (RESPOND ED): Study Protocol and Analysis Plan
Authors: Harley, Amanda; George, Shane; King, Megan; Phillips, Natalie; Keijzers, Gerben; Long, Debbie; Gibbons, Kristen; Bellomo, Rinaldo; Schlapbach, Luregn J.
Abstract: Introduction: Septic shock in children still carries substantial mortality and morbidity. While resuscitation with 40-60 mL/kg intravenous fluid boluses remains a cornerstone of initial resuscitation, an increasing body of evidence indicates potential for harm related to high volume fluid administration. We hypothesize that a protocol on early use of inotropes in children with septic shock is feasible and will lead to less fluid bolus use compared to standard fluid resuscitation. Here, we describe the protocol of the Early Resuscitation in Paediatric Sepsis Using Inotropes - A Randomised Controlled Pilot Study in the Emergency Department (RESPOND ED). Methods and analysis: The RESPOND ED study is an open label randomised controlled, two arm, multicentre pilot study conducted at four specialised paediatric Emergency Departments. Forty children aged between 28 days and 18 years treated for presumed septic shock will be randomized in a 1:1 ratio to early inotropes vs. standard fluid resuscitation. Early inotrope treatment is defined as the commencement of a continuous intravenous adrenaline infusion after 20 mL/kg fluid bolus resuscitation. Standard fluid resuscitation is defined as delivery of 40 to 60 mL/kg fluid bolus resuscitation prior to commencement of inotropes. In addition to feasibility outcomes, survival free of organ dysfunction censored at 28 days will be assessed as the main clinical outcome. The study cohort will be followed up at 28 days, and at 6 months post enrolment to assess quality of life and functional status. Biobanking nested in the study cohort will be performed to enable ancillary biomarker studies. Ethics and dissemination: The trial has ethical clearance (Children's Health Queensland, Brisbane, HREC/18/QCHQ/49168) and is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12619000828123). Enrolment commenced on July 21st, 2019. The primary manuscript will be submitted for publication in a peer-reviewed journal. Trial Registration: Australian and New Zealand Clinical Trials Registry, ACTRN12619000828123.2021-05-31T00:00:00Z