PERUKI research studies currently enrolling

Febrile Infants Diagnostic assessment and outcome (FIDO)

FIDO Febrile infants under 3 months of age are at higher risk of invasive and serious bacterial infections when compared to older children. Typically the approach to assessment and initial management of these infants involves blood testing, urinalysis, lumbar puncture and parenteral antibiotics. In the USA and Europe a number of studies have shown that a low risk cohort can be identified that are suitable for  fewer investigations and management without parenteral antibiotics. The FIDO study is a prospective observational cohort study funded by the Royal College of Emergency Medicine that aims to validate  clinical practice guidelines for the assessment and management of febrile infants. Commencing in July 2022 this NIHR portfolio study aims to recruit at least 1000 infants from PERUKI sites. For more information email fidostudy@qub.ac.uk

Button Batteries

Button batteries 

Button Battery ingestion is a potential life-threatening emergency. Current treatment practices vary. The aim of this surveillance study is to record any cases of button battery ingestion, insertion, or aspiration in children and young people aged under 16 years.  The study opened in February 2021 and is open until August 22.

Data entry is all electronic using two case report forms. The initial form is completed for the initial attendance and the second form completed after 28 days.

MAGPIE Methoxyflurane is an inhaled analgesic and anaesthetic agent.  As an analgesic agent (at low doses), methoxylurane has been used extensively within a number of ambulance services, Emergency Departments and armed forces in Australia and New Zealand, including more than 20 years of administration via the Penthrox inhaler (Medical Developments International).  Clinical indications include both traumatic and non-traumatic acute pain, and procedural pain, in both adult and paediatric populations.

Key advantages of Penthrox include rapid onset of analgesia, few minor side effects, compact size and ease of use, short recovery time and no requirement for opioid-related post-treatment monitoring.

Since October 2015, Penthrox has been licensed for use in the UK and Ireland for the emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain.

MAGPIE is a regulatory study which aims to demonstrate the clinical efficacy and safety of Penthrox in children and young people within the UK and Ireland, in order to extend the current license to the paediatric population.  It is a randomised, double-blind, placebo controlled study which will evaluate the safety and efficacy of Penthrox of acute pain associated with minor trauma in patients between the ages of 6 and 18 years.

9 PERUKI sites are participating in this study, with recruitment due to commence in July 2017.

Methoxy-flurane AnalGesia for Paediatric InjuriEs (MAGPIE)
Magnet Ingestions

Magnet ingestion

 

This prospective surveillance study aims to recruit children under 16 years with any attendance relating to ingestion of a magnet. Data collection is online using three forms (presentation, 7 days after, and 28 days after). The study opened on the 1st May 2022  and will run for 12 months. 

THE Children’s Radius Acute Fracture Fixation Trial (CRAFFT)

The UK is more interventional than many countries, including the USA, in the treatment of distal radius fractures in children. Standard UK treatment is surgical correction, whilst others often follow a non-operative approach. There is low quality evidence that these fractures heal well and completely correct themselves without surgery in children under 11 years old, even if bones are initially displaced. There is a clear and pressing need to inform patients about benefits or otherwise of treatment options, and a need to inform commissioners regarding the costs to the NHS and society. CRAFFT (The Children’s Radius Acute Fracture Fixation Trial) is a multi-centre prospective randomized non-inferiority trial of surgical reduction versus non-surgical casting for severely displaced off-ended distal radius fractures (metaphyseal or Salter Harris) in children aged 4 to 10 years. In this cross-network (PERUKI & BSCOS) study the primary outcome is the Patient Reported Outcomes Measurement Information System Upper Extremity Score for Children (PROMIS UE). The trial started in 2019 and recruitment will finish in 2023. The sample size is 750 children. More details here