Using high flow moist oxygen early to treat acute severe asthma in children

High flow humidified oxygen as an early intervention in children with acute severe asthma: a randomised controlled trial (High flow humidified oxygen in paediatric severe asthma)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN86214145

Enrollment

218

Registered

2026-02-20

Start date

2026-03-25

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute severe asthma in children Respiratory

Interventions

Eligible children will be randomised using an online software application to the HiFlo or usual care arm. This will be performed by clinical staff using a computer desktop link and administered by the

Eligibility

Sex/Gender

All

Age

2 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. CYP aged 2-18 years (up to and including the day before 19th birthday) 2. Acute severe asthma (ASA) presenting to hospital, defined as respiratory distress and documented wheeze – formal prior diagnosis of asthma not required 3. Required high dose “burst” inhaled bronchodilator therapy – 3 doses of salbutamol ± ipratropium ± nebulised magnesium 4. Failure to respond, defined as persisting hypoxaemia (pulse oxygen saturation less than 95% in air) with moderate or severe respiratory distress, at any point 1 to 4 hours after commencing burst.

Exclusion criteria

Exclusion criteria: 1. Clinical/radiological evidence of bacterial pneumonia: fever >38.5oC plus focal signs on auscultation or chest X-ray 2. Life-threatening asthma: signs of impending respiratory failure warranting imminent intubation 3. Impaired consciousness (AVPU score P or worse) 4. Contraindications to use of high flow humidified oxygen (HiFlo): air leak (pneumothorax, pneumomediastinum or subcutaneous emphysema), , recent (within 6 weeks) bowel surgery, intractable vomiting 5. Other major respiratory, cardiovascular or neurological condition 6. Previous participation in this study

Countries

England, Scotland, United Kingdom

Contacts

Public ContactHector Rojas Anaya

CTU-HOPSA@bsms.ac.uk+44 1273 641469

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026