Actively Recruiting

Phase 4
Age: 4Years - 15Years
All Genders
ID07402707

Dosing of Steroids for Acute Asthma Given in the Emergency Department - a Pilot Randomised Feasibility Trial of Dexamethasone in Children

Led by Sheffield Children's NHS Foundation Trust · Updated on 2026-04-23

104

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research focuses on children aged 4 to 15 years who experience asthma attacks, aiming to compare two different doses of the steroid dexamethasone given orally in emergency departments. The study evaluates which dose better reduces the need for repeat steroid prescriptions within two weeks after initial treatment. The study also examines how often children return to emergency care or their general practitioner and looks at how acceptable the treatments are to both parents and children. This pilot trial will help gather important information to plan a larger, more definitive study that addresses key concerns of families and healthcare professionals. Participants will receive one of two doses of dexamethasone, either 0.3 mg/kg or 0.6 mg/kg, as a single oral dose during their emergency department visit. The study is randomized and triple-blinded, meaning neither the participants, caregivers, nor researchers know which dose is given. The chosen doses reflect common clinical practices and aim to find the lowest effective dose to reduce side effects. This study period includes the initial emergency treatment and follow-up monitoring. Throughout the study, children will be monitored for the need for additional steroid treatment, hospital admissions, and how well they tolerate the medication. Researchers will track emergency department visits, general practitioner visits, and collect feedback from parents and children about the treatment experience. The primary outcome is participant recruitment over seven months, while secondary outcomes assess tolerability and hospital admissions. The study continues until August 2026, with careful safety monitoring by the research team.

CONDITIONS

Brief Title

Dosing of Steroids for Acute Asthma Given in the Emergency Department - a Pilot Randomised Feasibility Trial of Dexamethasone in Children

Who Can Participate

Age: 4Years - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 4 to 15 years (inclusive) presenting to the emergency department with an asthma exacerbation where oral steroids are recommended
  • Children whose parents or carers speak English or one of the common languages with interpreter support (Slovakian, Arabic, Urdu)
Not Eligible

You will not qualify if you...

  • Children treated with oral or intravenous steroids in the last 2 weeks
  • Known allergy to the study drug (dexamethasone)
  • Children with stridor (a breathing sound) along with asthma
  • First episode of wheezing not previously diagnosed as asthma
  • Children with difficult asthma needing longer steroid courses
  • Life-threatening asthma episode
  • Children with other conditions requiring steroids when unwell
  • Participation in current or recent research prior to recruitment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single dose administered during emergency department visit

Participants receive a single dose of dexamethasone at either 0.3 mg/kg or 0.6 mg/kg in the emergency department to treat an acute asthma exacerbation.

1 visit (in-person) in the emergency department

Follow-up

Duration - Up to 7 months

Participants are monitored for the need for retreatment with steroids and any additional medical care for asthma exacerbations after the initial treatment.

Follow-up contacts or visits as needed during 7 months

Trial Site Locations

Total: 1 location

1

Sheffield Children's NHS Foundation Trust

Sheffield, United Kingdom, S10 2TH

Actively Recruiting

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Research Team

M

Meena Balasubramanian

G

Gillian Gatenby

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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