Project Snapshot – KidsTHRIVE

Trans-nasal Humidified Rapid- Insufflation Ventilatory Exchange in Children Requiring Emergent Intubation

Aim
The aim of this study is to assess the effect of THRIVE as a method for prolonging apnoeic oxygenation during the emergency intubation of children to reduce the proportion adverse events (specifically, oxygen desaturation) and increase the proportion of first attempt success for endotracheal intubation.

Recruitment stats as @ 22/4/20

  • Study commenced 09/05/2021
  • Sample size: 960
  • Current Overall Enrolment Total: 674

Sites currently recruiting as @ 22/4/20

  • Queensland Children’s Hospital – ED & PICU
  • Children’s Hospital at Westmead – PICU
  • Gold Coast University Hospital – ED & PICU
  • Monash Children’s Hospital – ED & PICU
  • Perth Children’s Hospital – PICU
  • Royal Children’s Hospital, Melbourne – PICU & NICU
  • Townsville Hospital – ED & PICU
  • Women’s and Children’s Hospital PICU

Planned to start recruitment in 2021

  • Planned to start recruitment in 2021
  • BC Children’s Hospital Vancouver – PICU
  • University Children’s Hospital Zurich – PICU

News:
1,780 children have been screen for inclusion into the KIDS THRIVE study and to date 674 have been randomised and consented. Of the enrolled children approximately 12% have been intubated in the ED, 81% in the PICU and 7% in the NICU. This study has been approved for consent to continue (delayed consent) due to the emergent nature of intubations. In 2020 a systematic, prioritized, risk-based approach to monitoring the KIDS THRIVE project was undertaken and centralised in depth source documentation verification and monitoring of the trial has now commenced.

The Kids THRIVE Trial Steering Committee (TSC) had complex discussions in March 2020 regarding the unfolding COVID-19 health crisis and the unique nature of the coronavirus infection and disease in children and recommended the study not be paused and that sites be allowed to develop their own local plan on how to manage the recruitment of patients. In order to support sites the protocol was amended to allow for verbal consent to be obtained by the research staff.

The KIDS THRIVE study received initial seed funding from the Emergency Medicine Foundation, and additional funding from the Thrasher Research Fund and the National Health and Medical Research Council.

 

PI and RA Research Training Days – Melbourne 21 & 22 June

A number of multicentre studies will commence with the PREDICT network over the next few months.  These studies include PROMPT Bolus, SONIC, PeaChY O and CHOICE UTI.  In order for sites to be educated on all studies, we are planning a PI/ Research Nurse education session at the Royal Children’s Hospital, Melbourne on Monday 21st and Tuesday 22nd June 2021.

We invite all PI’s and research nurses to fly to Melbourne to attend this training.  We have run similar education days in the past and they have been extremely successful, both for the research nurses recruiting for the studies and the PI’s overseeing the local sites. We highly recommend that you attend. We will cover all study related topics including governance applications, study oversight, in depth study specific education, databases, legal contracts, GCP and recruitment.

Accommodation and flights will be covered by study budgets and organised by PREDICT administration assistant, Marian Chandler.

Please save these dates in your diaries.  Further information, including the process for booking flights and accommodation, will be emailed in coming weeks.

 

 

 

 

Project Snapshot – PEAChY-O

PEAChY-0: Pharmacological Emergency management of Agitation in Children and Young people – A randomised controlled trial of Oral medication

Trial Design:
Pragmatic, open-label, multi-centre, phase III superiority, randomised controlled trial (RCT).

Aim:
To determine in children and adolescents aged ≥7 years to <18 years with acute severe behavioural disturbance (ASBD) whether oral olanzapine is more effective than oral diazepam at achieving successful sedation at 30 minutes, without the requirement of additional medication or the presence of medication related adverse events. The Sedation Assessment Tool (SAT) will be used to score sedation and agitation levels – a SAT of ≤0 will be considered “successful sedation”.

Setting & Target:
7 PREDICT paediatric ED sites in Australia. A total of 348 participants will be recruited.

  • Royal Children’s Hospital Melbourne – HREC approval obtained 5th March. Recruitment to commence on 1st June, 2021
  • Monash Medical Centre
  • Perth Children’s Hospital
  • Women’s and Children’s Hospital, Adelaide
  • Children’s Hospital at Westmead
  • Gold Coast University Hospital
  • Queensland Children’s Hospital

Status:
RCH Ethics approved. RCH Ethics amendment approval pending. Local governance applications at all sites will commence shortly after approval obtained. Anticipated commencement date at lead site (RCH) June 1st, 2021.

Update: The PEAChY-M: Pharmacological Emergency management of Agitation in Children and Young people – A randomised controlled trial of intraMuscular medication trial protocol has been distributed for review by the steering committee members. It will be submitted to RCH HREC in May.

New PREDICT publications

Congratulations to the following authors:

Haskell L, Tavender EJ, Wilson CL, O’Brien S, Babl FE, Borland ML, Cotterell E, Schembri R, Orsini F, Sheridan N, Johnson DW, Oakley E, Dalziel SR; PREDICT Network. Effectiveness of Targeted Interventions on Treatment of Infants With Bronchiolitis: A Randomized Clinical Trial. JAMA Pediatr. 2021 Apr 12. doi: 10.1001/jamapediatrics.2021.0295. Epub ahead of print. PMID: 33843971.

See link to review of the paper on the DFTB website here.

 

New PREDICT publications

Congratulations to the following authors:

Babl FE, Tavender E, Dalziel SR; Paediatric Research in Emergency Departments International Collaborative (PREDICT).
From knowledge generation to synthesis to translation.
Emerg Med Australas. 2021 Apr;33(2):192-194

Project snapshot: APSOS-1

Australian and New Zealand Prospective Sepsis Observational Study-1 

Multi-centre, prospective observational study to investigate the prevalence, management, and outcomes of children with sepsis.

Setting and target: 

>10 PREDICT sites in Australia and New Zealand.

Inclusion criteria:

Age <18 years, requiring hospital admission for admission for IV/IM/IO antibiotics, circulatory support (IV fluid bolus or inotrope).Children aged 6 months – 18 years, requiring hospital admission for sepsis and >1 fluid bolus.

Exclusion criteria:

Patients receiving inotrope / vasopressor for indications other than sepsis, post-operative cardiac surgical patients, post-operative solid organ transplant patients.

Ethics and consent:

Ethics approval for verbal consent for 90-day follow-up (text, email, or phone); enrol patient when meeting inclusion criteria. Consent by enrolling clinician or within 24 hours by research team.

Status:

APSOS 1 will begin recruitment in March 2021 (in conjunction with PROMPT Bolus), study duration 1 year.

Study duration:

1 year.

Project snapshot – Prompt Bolus

Pragmatic Paediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS)

A pragmatic, international randomised controlled trial comparing 0.9% saline to balanced fluids for sepsis resuscitation and initial maintenance.

This study aims to:

To evaluate the effectiveness and safety of balanced fluids for sepsis resuscitation and initial maintenance compared to 0.9% saline.

Setting and target: 

>10 PREDICT sites in Australia and New Zealand; 2200 patients; MRFF funded. 23 PECARN (US) sites; 4500 patients; NIH funded. 12 PERC (Can) sites; 2600 patients; CIHR funded.

Primary outcome:

Major Adverse Kidney Events (MAKE 30) at hospital discharge or within 30 days of enrolment (death, requirement for renal replacement therapy, persistent renal dysfunction).

Inclusion criteria:

Children aged 6 months – 18 years, requiring hospital admission for sepsis and >1 fluid bolus.

Exclusion criteria:

40ml/kg fluid, clinician judgement not safe (suspected brain herniation, known hyperkalaemia / hypercalcaemia / hepatic or renal failure, known metabolic or mitochondrial disease, known pregnancy, known fluid allergy.

Ethics and consent:

Ethics approval for delayed consent (waiver of consent to randomise). Consent by the research team once patient stabilised.

Status:

PROMPT Bolus will begin recruitment at RCH in March 2021, study duration 4.5 years. Enrolment in the US started in August 2020. Enrolment in Canada has not yet started.

Australian and New Zealand sites:
  • Kidz First Hospital, Middlemore (NZ)
  • Waikato Hospital (NZ)
  • Starship Hospital (NZ)
  • Royal Darwin Hospital (NT)
  • Gold Coast University Hospital (QLD)
  • Queensland Children’s Hospital (QLD)
  • Westmead Children’s Hospital (NSW)
  • Sydney Children’s Hospital (NSW)
  • Perth Children’s Hospital, Perth (WA)
  • Monash Health
  • Women’s and Children’s Hospital, Adelaide (SA)
  • The Royal Children’s Hospital (VIC)
  • Townsville Hospital (QLD)

Project snapshot – SONIC

Study of Neck Injury Imaging in Children (SONIC): Improving the Diagnosis of Spinal Cord, Bone and Ligament Injuries

Many children sustain head and neck trauma during their lifetime. Significant neck injuries – to spinal cord, neck bones and connecting ligaments – can be identified by performing neck imaging with x-rays, or, if needed, computed tomography or magnetic resonance imaging. Yet, it is unclear which children should receive neck imaging in the emergency department (ED), especially in the context of increasing concerns about radiation-induced cancer in children and the discomfort and delays of immobilisation prior to imaging.

This study aims to:

(i) investigate the accuracy of existing neck injury clinical decision rules (CDRs) to detect neck injuries in children (external validation) of adult focussed CDRs and the newly developed paediatric PECARN CDR
(ii) derive and validate a new CDR for neck imaging in children (the SONIC CDR),
(iii) assess the cost implications of different CDRs in children.
(iv) investigate the epidemiology of cervical spine injuries in ANZ

Study design: 

Multicentre, prospective observational study.

Timeframe:

2020 – 2025

Sites:
  • Royal Children’s Hospital, Melbourne (VIC)
  • Monash Children’s Hospital, Melbourne (VIC)
  • Queensland Children’s Hospital (QLD)
  • Logan Hospital (QLD)
  • Sunshine Coast University Hospital (QLD)
  • Gold Coast University Hospital (QLD)
  • Perth Children’s Hospital, Perth (WA)
  • Children’s Hospital at Westmead (NSW)
  • Sydney Children’s Hospital (NSW)
  • Women’s and Children’s Hospital, Adelaide (SA)
  • Darwin Hospital (NT)
  • Kids First, Auckland (NZ)
  • Starship Children’s Hospital, Auckland (NZ)
Sample:

PREDICT ~30,000 (depending on prevalence of injuries), children aged <16 yrs with possible neck injury.

News:

We are currently finalising the ethics approval which includes waiver of consent for enrolment and data collection and verbal consent required only for telephone/text/email follow up. Development of the CRFs and Redcap data base is underway in view of a rolling study commencement to begin in May.

New PREDICT publications

The following manuscripts have been published.  Congratulations to the authors.

Franklin D, Shellshear D, Babl FE, Hendrickson R, Williams A, Gibbons K, McEnery K, Kennedy M, Pham TM, Acworth J, Levitt D, Oakley E, Schibler A; PARIS and PREDICT. High flow in children with respiratory failure: A randomised controlled pilot trial – A paediatric acute respiratory intervention study. J Paediatr Child Health. 2020 Dec 30. doi: 10.1111/jpc.15259. Epub ahead of print. PMID: 33377568. [link]

Babl FE, Tavender E, Ballard DW, Borland ML, Oakley E, Cotterell E, Halkidis L, Goergen S, Davis GA, Perry D, Anderson V, Barlow KM, Barnett P, Bennetts S, Bhamjee R, Cole J, Craven J, Haskell L, Lawton B, Lithgow A, Mullen G, O’Brien S, Paproth M, Wilson CL, Ring J, Wilson A, Leo GS, Dalziel SR; Paediatric Research in Emergency Departments International Collaborative (PREDICT). Australian and New Zealand Guideline for Mild to Moderate Head Injuries in Children. Emerg Med Australas. 2021 Feb 2. doi: 10.1111/1742-6723.13722. Epub ahead of print. PMID: 33528896. [link]

Tavender E, Ballard DW, Wilson A, Borland ML, Oakley E, Cotterell E, Wilson CL, Ring J, Dalziel SR, Babl FE; Paediatric Research in Emergency Departments International Collaborative (PREDICT). Review article: Developing the Australian and New Zealand Guideline for Mild to Moderate Head Injuries in Children: An adoption/adaption approach. Emerg Med Australas. 2021 Feb 2. doi: 10.1111/1742-6723.13716. Epub ahead of print. PMID: 33528917. [link]

Lim JC, Borland ML, Middleton PM, Moore K, Shetty A, Babl FE, Lee RS, Acworth J, Wilson C, Than M, Craig S; ACEM EDEN and the PREDICT Network. Where are children seen in Australian emergency departments? Implications for research efforts. Emerg Med Australas. 2021 Jan 3. doi: 10.1111/1742-6723.13698. Epub ahead of print. PMID: 33393221. [link]

Florin TA, Tancredi DJ, Ambroggio L, Babl FE, Dalziel SR, Eckerle M, Mintegi S, Neuman M, Plint AC, Kuppermann N; Pediatric Emergency Research Networks (PERN) Pneumonia Investigators. Predicting severe pneumonia in the emergency department: a global study of the Pediatric Emergency Research Networks (PERN)-study protocol. BMJ Open. 2020 Dec 2;10(12):e041093. doi: 10.1136/bmjopen-2020-041093. PMID: 33268423; PMCID: PMC7713188. [link]

Wilson CL, Hearps SJ, Tavender EJ, Phillips NT, Lawton B, Kinnear F, Beattie A, Mitenko H, Young R, Cole J, Kochar A, George S, Teo SS, Georgeson T, Michael A, Mukherjee A, King A, Gamage L, Archer P, Cassidy C, Rao A, Thosar D, Borland ML, Babl FE. Factors predictive for computed tomography use and abnormality in paediatric head injuries in Australia and New Zealand. Emerg Med Australas. 2020 Dec 22. doi: 10.1111/1742-6723.13694. Epub ahead of print. PMID: 33354919. [link]

Babl FE, Lyttle MD, Phillips N, Kochar A, Dalton S, Cheek JA, Furyk J, Neutze J, Bressan S, Williams A, Hearps SJC; MBiostat, Oakley E, Davis GA, Dalziel SR, Borland ML. Mild traumatic brain injury in children with ventricular shunts: a PREDICT study. J Neurosurg Pediatr. 2020 Nov 20:1-7. doi: 10.3171/2020.7.PEDS2090. [Epub ahead of print]. PMID: 33254139. [link]

Nagler J, Auerbach M, Monuteaux MC, Cheek JA, Babl FE, Oakley E, Nguyen L, Rao A, Dalton S, Lyttle MD, Mintegi S, Mistry RD, Dixon A, Rino P, Kohn-Loncarica G, Dalziel S, Craig S, the Paediatric Emergency Research Networks (PERN). Exposure and confidence across critical airway procedures in pediatric emergency medicine: An international survey study. J. Emerg. April 2021. 42:70-77. Doi: 10.1016/j.ajem.2020.12.075. [Epub ahead of print]. [link]

 

RHD and RA positions appointed

Following the nomination process, the following appointments on the PREDICT executive have been made:

Research Higher Degree scholar: Brooke Charters (2021 & 2022)
Research Assistant: Libby Haskell (2021) & Michael McCarron (2022)

Congratulations to the successful nominees. We look forward to your involvement on the PREDICT executive.