Early high flow nasal cannula therapy in bronchiolitis, a prospective randomised control trial (protocol): A Paediatric Acute Respiratory Intervention Study (PARIS)

Background Bronchiolitis imposes the largest health care burden on non-elective paediatric hospital admissions worldwide, with up to 15 % of cases requiring admission to intensive care. A number of previous studies have failed to show benefit of pharmaceutical treatment in respect to length of stay, reduction in PICU admission rates or intubation frequency. The early use of non-invasive respiratory support devices in less intensive scenarios to facilitate earlier respiratory support may have an impact on outcome by avoiding progression of the disease process. High Flow Nasal Cannula (HFNC) therapy has emerged as a new method to provide humidified air flow to deliver a non-invasive form of positive pressure support with titratable oxygen fraction. There is a lack of high-grade evidence on use of HFNC therapy in bronchiolitis. Methods/Design Prospective multi-centre randomised trial comparing standard treatment (standard subnasal oxygen) and High Flow Nasal Cannula therapy in infants with bronchiolitis admitted to 17 hospitals emergency departments and wards in Australia and New Zealand, including 12 non-tertiary regional/metropolitan and 5 tertiary centres. The primary outcome is treatment failure; defined as meeting three out of four pre-specified failure criteria requiring escalation of treatment or higher level of care; i) heart rate remains unchanged or increased compared to admission/enrolment observations, ii) respiratory rate remains unchanged or increased compared to admission/enrolment observations, iii) oxygen requirement in HFNC therapy arm exceeds FiO2 ≥ 40 % to maintain SpO2 ≥ 92 % (or ≥94 %) or oxygen requirement in standard subnasal oxygen therapy arm exceeds >2L/min to maintain SpO2 ≥ 92 % (or ≥94 %), and iv) hospital internal Early Warning Tool calls for medical review and escalation of care. Secondary outcomes include transfer to tertiary institution, admission to intensive care, length of stay, length of oxygen treatment, need for non-invasive/invasive ventilation, intubation, adverse events, and cost. Discussion This large multicenter randomised trial will allow the definitive assessment of the efficacy of HFNC therapy as compared to standard subnasal oxygen in the treatment of bronchiolitis

51 Paediatric emergency clinicians are rarely exposed to non-airway critical procedures: a predict/PERN study

© 2017, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions. BACKGROUND: Recent studies suggest that approximately one per thousand paediatric ED attendances may require some sort of critical procedure, with intubation being by far the most common. It is unknown how often critical non-airway procedures such as chest decompression, CPR, ED thoracotomy, defibrillation, pacing, and advanced vascular access techniques are performed by paediatric emergency clinicians.OBJECTIVE: To determine the recent performance or supervision, and confidence for various paediatric critical non-airway procedures by senior paediatric emergency clinicians.DESIGN/METHODS: Web based survey of senior paediatric emergency clinicians regarding performance, supervision, and confidence relating to critical non-airway procedures in children aged 0-18 years. The survey was distributed through Paediatric Emergency Research Networks (PERN) in the UK and Ireland, USA, Canada, Europe, South America, Australia and New Zealand.RESULTS: 1602 clinicians responded to the survey, with an overall response rate of 65%. 1508 (94%) respondents reported their most recent non-airway procedural experience. In the last 12 months, 979 (64%) had personally inserted an intraosseous line, 283 (19%) a central venous line, and 265 (18%) an arterial line. In the same time period, 962 (64%) had performed CPR, 190 (13%) had performed needle thoracostomy, 245 (16%) had performed tube thoracostomy, 380 (25%) had performed DC cardioversion or defibrillation, and 57 (4%) had performed transcutaneous pacing. 18 (1%) had performed pericardiocentesis, 19 (1%) a venous cutdown, and 21 (1%) ED thoracotomy. More than 70% of respondents had never supervised or performed pacing, pericardiocentesis, venous cutdown or ED thoracotomy. 332 (22%) and 348 (23%) had never performed or supervised insertion of a central venous line or arterial line respectively.Procedural confidence for intraosseous lines and CPR was high, while confidence increased with increasing patient age for central venous access and arterial lines. ED thoracotomy, pericardiocentesis and venous cutdown had the lowest frequency of respondents reporting confidence in performing the procedure.CONCLUSIONS: More than half of the paediatric emergency clinicians surveyed had performed CPR and inserted an intraosseous needle within the last 12 months. Performance of other non-airway critical procedures was less common, and associated with less procedural confidence

A prospective randomised trial comparing nasogastric with intravenous hydration in children with bronchiolitis (protocol) The comparative rehydration in bronchiolitis study (CRIB)

<p>Abstract</p> <p>Background</p> <p>Bronchiolitis is the most common reason for admission of infants to hospital in developed countries. Fluid replacement therapy is required in about 30% of children admitted with bronchiolitis. There are currently two techniques of fluid replacement therapy that are used with the same frequency-intravenous (IV) or nasogastric (NG).</p> <p>The evidence to determine the optimum route of hydration therapy for infants with bronchiolitis is inadequate. This randomised trial will be the first to provide good quality evidence of whether nasogastric rehydration (NGR) offers benefits over intravenous rehydration (IVR) using the clinically relevant continuous outcome measure of duration of hospital admission.</p> <p>Methods/Design</p> <p>A prospective randomised multi-centre trial in Australia and New Zealand where children between 2 and 12 months of age with bronchiolitis, needing non oral fluid replacement, are randomised to receive either intravenous (IV) or nasogastric (NG) rehydration.</p> <p>750 patients admitted to participating hospitals will be recruited, and will be followed daily during the admission and by telephone 1 week after discharge. Patients with chronic respiratory, cardiac, or neurological disease; choanal atresia; needing IV fluid resuscitation; needing an IV for other reasons, and those requiring CPAP or ventilation are excluded.</p> <p>The primary endpoint is duration of hospital admission. Secondary outcomes are complications, need for ICU admission, parental satisfaction, and an economic evaluation. Results will be analysed using t-test for continuous data, and chi squared for categorical data. Non parametric data will be log transformed.</p> <p>Discussion</p> <p>This trial will define the role of NGR and IVR in bronchiolitis</p> <p>Trail registration</p> <p>The trial is registered with the Australian and New Zealand Clinical Trials Registry - ACTRN12605000033640</p

Interleukin-8 predicts fatigue at 12 months post-injury in children with traumatic brain injury

Despite many children experiencing fatigue after childhood brain injury, little is known about the predictors of this complaint. To date, traditional indices of traumatic brain injury (TBI) severity have not reliably predicted persisting fatigue (up to 3 years post‐injury). This study aimed to establish if persisting fatigue is predicted by serum biomarker concentrations in child TBI. We examined if acute serum biomarker expression would improve prediction models of 12‐month fatigue based on injury severity. Blood samples were collected from 87 children (1 – 17 years at injury) sustaining mild to severe TBI (GCS range 3‐15; mean 12.43; classified as mild TBI (n=50, 57%) vs moderate/severe TBI n=37, 43%), and presenting to the Emergency Departments (ED) and Pediatric Intensive Care Units (PICU) at one of three tertiary pediatric hospitals (Royal Children’s Hospital (RCH); Hospital for Sick Children (HSC), Toronto St Justine Children’s Hospital (SJH), Montreal). Six serum biomarker concentrations were measured within 24 hours of injury [interleukin‐6 (IL‐6), interleukin‐8 (IL‐8), soluble vascular cell adhesion molecule (SVCAM), S100 calcium binding protein B (S100B), neuron specific enolase (NSE), and soluble neural cell adhesion molecule (sNCAM)]. Fatigue at 12 months post‐injury was measured using the Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (parent report), classified as present/absent using previously derived cut‐points. At 12 months post‐injury, 22% of participants experienced fatigue. A model including interleukin‐8 (IL‐8) was the best serum biomarker for estimating the probability of children experiencing fatigue at 12 months post‐injury. IL‐8 also significantly improved predictive models of fatigue based on severity

Traumatic brain injury in young children with isolated scalp haematoma

Objective Despite high-quality paediatric head trauma clinical prediction rules, the management of otherwise asymptomatic young children with scalp haematomas (SH) can be difficult. We determined the risk of intracranial injury when SH is the only predictor variable using definitions from the Pediatric Emergency Care Applied Research Network (PECARN) and Children’s Head Injury Algorithm for the Prediction of Important Clinical Events (CHALICE) head trauma rules.Design Planned secondary analysis of a multicentre prospective observational study.Setting Ten emergency departments in Australia and New Zealand.Patients Children 5 cm haematoma in any region of the head) rule-based definition of isolated SH in both childre

A Randomized Trial of High-Flow Oxygen Therapy in Infants with Bronchiolitis

BACKGROUND: High-flow oxygen therapy through a nasal cannula has been increasingly used in infants with bronchiolitis, despite limited high-quality evidence of its efficacy. The efficacy of high-flow oxygen therapy through a nasal cannula in settings other than intensive care units (ICUs) is unclear. METHODS: In this multicenter, randomized, controlled trial, we assigned infants younger than 12 months of age who had bronchiolitis and a need for supplemental oxygen therapy to receive either high-flow oxygen therapy (high-flow group) or standard oxygen therapy (standard-therapy group). Infants in the standard-therapy group could receive rescue high-flow oxygen therapy if their condition met criteria for treatment failure. The primary outcome was escalation of care due to treatment failure (defined as meeting ≥3 of 4 clinical criteria: persistent tachycardia, tachypnea, hypoxemia, and medical review triggered by a hospital early-warning tool). Secondary outcomes included duration of hospital stay, duration of oxygen therapy, and rates of transfer to a tertiary hospital, ICU admission, intubation, and adverse events. RESULTS: The analyses included 1472 patients. The percentage of infants receiving escalation of care was 12% (87 of 739 infants) in the high-flow group, as compared with 23% (167 of 733) in the standard-therapy group (risk difference, −11 percentage points; 95% confidence interval, −15 to −7; P<0.001). No significant differences were observed in the duration of hospital stay or the duration of oxygen therapy. In each group, one case of pneumothorax (<1% of infants) occurred. Among the 167 infants in the standard-therapy group who had treatment failure, 102 (61%) had a response to high-flow rescue therapy. CONCLUSIONS: Among infants with bronchiolitis who were treated outside an ICU, those who received high-flow oxygen therapy had significantly lower rates of escalation of care due to treatment failure than those in the group that received standard oxygen therapy. (Funded by the National Health and Medical Research Council and others; Australian and New Zealand Clinical Trials Registry number, ACTRN12613000388718.

Nasal high flow in room air for hypoxemic bronchiolitis infants

Background: Bronchiolitis is the most common reason for hospital admission in infants, with one third requiring oxygen therapy due to hypoxemia. It is unknown what proportion of hypoxemic infants with bronchiolitis can be managed with nasal high-flow in room air and their resulting outcomes. Objectives and Settings: To assess the effect of nasal high-flow in room air in a subgroup of infants with bronchiolitis allocated to high-flow therapy in a recent multicenter randomized controlled trial. Patients and Interventions: Infants allocated to the high-flow arm of the trial were initially treated with room air high-flow if saturations were ≥85%. Subsequently, if oxygen saturations did not increase to ≥92%, oxygen was added and FiO2 was titrated to increase the oxygen saturations. In this planned sub-study, infants treated during their entire hospital stay with high-flow room air only were compared to infants receiving either standard-oxygen or high-flow with oxygen. Baseline characteristics, hospital length of stay and length of oxygen therapy were compared. Findings: In the per protocol analysis 64 (10%) of 630 infants commenced on high-flow room air remained in room air only during the entire stay in hospital. These infants on high-flow room air were on average older and presented with moderate hypoxemia at presentation to hospital. Their length of respiratory support and length of stay was also significantly shorter. No pre-enrolment factors could be identified in a multivariable analysis. Conclusions: In a small sub-group of hypoxemic infants with bronchiolitis hypoxemia can be reversed with the application of high-flow in room air only

Accuracy of PECARN, CATCH, and CHALICE head injury decision rules in children: a prospective cohort study

© 2017 Elsevier Ltd Background Clinical decision rules can help to determine the need for CT imaging in children with head injuries. We aimed to validate three clinical decision rules (PECARN, CATCH, and CHALICE) in a large sample of children. Methods In this prospective observational study, we included children and adolescents (age

A multicentre randomised controlled trial of levetiracetam versus phenytoin for convulsive status epilepticus in children (protocol): Convulsive Status Epilepticus Paediatric Trial (ConSEPT) - a PREDICT study

Background: Convulsive status epilepticus (CSE) is the most common life-threatening childhood neurological emergency. Despite this, there is a lack of high quality evidence supporting medication use after first line benzodiazepines, with current treatment protocols based solely on non-experimental evidence and expert opinion. The current standard of care, phenytoin, is only 60% effective, and associated with considerable adverse effects. A newer anti-convulsant, levetiracetam, can be given faster, is potentially more efficacious, with a more tolerable side effect profile. The primary aim of the study presented in this protocol is to determine whether intravenous (IV) levetiracetam or IV phenytoin is the better second line treatment for the emergency management of CSE in children. Methods/Design: 200 children aged between 3 months and 16 years presenting to 13 emergency departments in Australia and New Zealand with CSE, that has failed to stop with first line benzodiazepines, will be enrolled into this multicentre open randomised controlled trial. Participants will be randomised to 40 mg/kg IV levetiracetam infusion over 5 min or 20 mg/kg IV phenytoin infusion over 20 min. The primary outcome for the study is clinical cessation of seizure activity five minutes following the completion of the infusion of the study medication. Blinded confirmation of the primary outcome will occur with the primary outcome assessment being video recorded and assessed by a primary outcome assessment team blinded to treatment allocation. Secondary outcomes include: Clinical cessation of seizure activity at two hours; Time to clinical seizure cessation; Need for rapid sequence induction; Intensive care unit (ICU) admission; Serious adverse events; Length of Hospital/ICU stay; Health care costs; Seizure status/death at one-month post discharge. Discussion: This paper presents the background, rationale, and design for a randomised controlled trial comparing levetiracetam to phenytoin in children presenting with CSE in whom benzodiazepines have failed. This study will provide the first high quality evidence for management of paediatric CSE post first-line benzodiazepines. Trial registration: Prospectively registered with the Australian and New Zealand Clinical Trial Registry (ANZCTR): ACTRN12615000129583(11/2/2015). UTN U1111-1144-5272. ConSEPT protocol version 4 (12/12/2014).The study is funded by grants from the Health Research Council of New Zealand (HRC 12/525), Auckland, New Zealand; A+ Trust (Auckland District Health Board), Auckland, New Zealand; Queensland Emergency Medicine Research Foundation, Milton, Queensland, Australia (EMPJ-105R21–2014- FURYK); Private Practice Research and Education Trust Fund, The Townsville Hospital and Health Service, Douglas, Queensland, Australia; Eric Ormond Baker Charitable Fund, Equity Trustees, Clayton, Victoria, Australia; and Princess Margaret Hospital Foundation, Perth, Western Australia, Australia. The PREDICT network is supported as a Centre of Research Excellence for Paediatric Emergency Medicine by the National Health and Medical Research Council, Canberra, Australian Capital Territory, Australia (NHMRC GNT1058560). The Victorian sites were supported by the Victorian Government’s Infrastructure Support Program, Melbourne, Victoria, Australia. FEB’s time was part funded by a grant from the Murdoch Childrens Research Institute and the Royal Children’s Hospital Foundation, Melbourne, Victoria, Australia. SRD’s time was part funded by the Health Research Council of New Zealand (HRC13/556). The study sponsor is Starship Children’s Health, Private Bag 92,024, Auckland 1142, New Zealan