STUDIES | peruki

PERUKI research studies currently enrolling

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

CRESCENT

Convulsive status epileptics (CSE) is the commonest neurological emergency seen in paediatric emergency departments and an important cause of preventable neurological disability and death. A large body of preclinical evidence suggests that pH is an important factor in both seizure onset and seizure termination, with the former occurring under alkaline and the latter under acidic conditions. CRESCENT is a trial evaluating the safety and efficacy of a potential new contribution to the management of status, using modest pH manipulation (achieved by substituting 100% high flow oxygen with a mixture of 95% oxygen 5% CO2, supplied in small, overpainted, CD size cylinders) to induce mild acidosis alongside standard medical (APLS) management to see if this increases the success rate of first line treatment.

CRESCENT builds on the ECLiPSE trial run so successfully by PERUKI several years ago using a similar, but simplified, design; again with a deferred consent approach. No randomisation is required at the time of treatment, and no additional samples, procedures or outcome assessments are required.

The trial opened in Summer 2023 with eight PERUKI sites open currently with four additional sites being opened. An interim analysis after 50% enrolment (provisionally late 2024) will determine whether the study continues.

CURLY

Overview
This trial aims to identify the optimal duration of oral cefalexin treatment for infants and young children diagnosed with febrile urinary tract infection (UTI). Current practice varies widely, and evidence is limited.

Study Design

Type: Multi-centre, open-label, multi-arm randomised controlled trial
Approach: “DURATIONS design” to generate a cefalexin duration vs. cure rate curve
Sites: 10 paediatric emergency departments across the UK (PERUKI network)

Participants

Population: Infants and children with febrile UTI, already prescribed oral cefalexin
Intervention: Randomised to one of five treatment durations — 3, 5, 6, 8, or 10 days
Allocation: Central randomisation with balancing for age, sex, and site

Primary Outcome

Clinical cure: Defined as fever resolution and no need for additional systemic antibiotics within 16 days post-randomisation

Contact For more information, please email: curly@trials.bham.ac.uk

FROG

Urinary tract infections (UTIs) are the second most common serious bacterial infection in children. When a UTI is suspected, healthcare professionals typically perform a urine test. The recommended method for collecting urine is a midstream sample, but this can be difficult or impossible for infants and young children.

Alternative methods include:

Non-invasive techniques (e.g., clean catch): painless but slow and prone to contamination.
Invasive techniques (e.g., catheterisation or suprapubic aspirate): faster and more accurate but may cause discomfort or distress.

Currently, there is no UK-based trial to determine which method should be offered when a midstream sample isn’t possible. This feasibility study aims to assess whether a full-scale randomised controlled trial (RCT) comparing these methods is achievable—and if so, how it should be designed.

Study Design
This mixed-methods feasibility study includes three key parts:

Feasibility RCT
A multicentre trial involving 100 infants, children, and young people will compare invasive and non-invasive urine collection methods. Resource use will be evaluated through parent questionnaires and healthcare professional feedback.
Perspectives Study
Interviews and focus groups will explore the views of:
- Parents (15–20 participants)
- Children and young people (10–15 participants)
- Healthcare professionals (up to 10 interviews and 5 focus groups)
This will assess the acceptability and practicality of the trial.
Stakeholder Consensus Meeting
A group of 40 stakeholders will meet to agree on the final design of a future definitive RCT.

Next Steps
Findings from this feasibility study will guide the development of a full-scale trial to improve urine sampling practices for children with suspected UTIs who cannot provide a midstream sample.

BACHb

Overview
Bronchiolitis is a leading cause of hospitalisation in infants, yet the best oxygen therapy approach remains unclear. The BACHb trial is the largest clinical study of its kind, aiming to determine whether high-flow nasal cannula (HFNC) is more effective than current standard treatments in reducing hospital stay for infants with moderate or severe bronchiolitis.

Research Questions

For infants with moderate bronchiolitis not responding to low-flow oxygen, is HFNC better than humidified standard oxygen (HSO)?
For infants with severe bronchiolitis, is HFNC better than nasal CPAP?

Study Design

Type: Multicentre, open-label, randomised clinical trial with health economic evaluation.
Sites: 50 NHS hospitals across the UK.
Participants: Infants under 12 months hospitalised with bronchiolitis.
Strata: Moderate and severe illness groups.
Primary Outcome: Time to hospital discharge.
Secondary Outcomes: Treatment failure, ICU admission, intubation, feeding milestones, comfort, readmission, and cost-effectiveness.

Consent & Ethics
Due to the emergency nature of treatment, consent is deferred until after randomisation. All treatments are already in routine clinical use.

Timeline & Impact

Duration: 42 months
Goal: To inform national and international bronchiolitis treatment guidelines.
Dissemination: Results will be shared via medical journals, public media, and the study website.

COWS

Significant injuries remain a leading cause of death and disability in children and young people. Many of these deaths are linked to severe bleeding. This study aims to better understand how bleeding occurs and worsens, using anonymised data from injuries treated between 2016 and 2023.

What’s Being Studied? Researchers will analyse archived hospital data to explore:

How bleeding is recognised and managed
The role of vital signs and blood test results (especially calcium levels)
Links between low calcium and outcomes like disability or death

Data Privacy

All patient data is fully anonymised before analysis
No identifiable information is shared with researchers
Age and gender are recorded in broad categories
Injury types are classified as blunt or penetrating, without specific details

Key Information Collected

Vital signs: Blood pressure, heart rate, breathing rate, oxygen levels
Blood tests: Calcium and other markers linked to bleeding
Treatment outcomes: Blood transfusions, surgery, recovery, and survival

Why It Matters
By analysing this data, researchers hope to improve how bleeding is managed in injured children—potentially saving lives and reducing long-term harm.