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Effectiveness of early high flow nasal cannula versus conventional oxygen therapy in moderate to severe exacerbation of asthma in children aged 2-14 years-Open Label Randomized Controlled Trial

Effectiveness of early high flow nasal cannula versus conventional oxygen therapy in moderate to severe exacerbation of asthma in children aged 2-14 years - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109795
Enrollment
104
Registered
2026-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: J454- Moderate persistent asthma

Interventions

Intervention1: High flow nasal cannula: Intervention (HFNC): HFNC will be be commenced within 30 min of randomisation and increase to a target of 2 l per kg per min for the first 10 kg body weight, pl

Sponsors

AIl India Institute of Medical SciencesVijaypur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Age between 2-14 years 2 Physician diagnosed asthma in more than 5 years and less than 5 year children as per GINA guideline 3 Clinical diagnosis of moderate to severe bronchial asthma exacerbation (first episode or recurrent episode) 4 Oxygen requirement on admission and 1 hour of initial therapy (spo2 less than 92 percent on room air at triage and following initial therapy) 5 Informed consent (written ,informed consent obtained from parent/guardian or assent obtained from children more than 7 years as per ethics guidelines

Exclusion criteria

Exclusion criteria: 1. Clinical and/or radiological evidence of lower respiratory tract infection (e.g., pneumonia) 2. Clinical and/or radiological evidence of acute bronchiolitis 3. Other underlying chronic respiratory illnesses(conditions such as -cystic fibrosis ,bronchopulmonary dysplasia ,Primary ciliary dyskinesia,Interstitial lung disease) 4. Congenital or acquired cardiac disease(Cyanotic or acyanotic congenital heart disease, heart failure, cardiomyopathy.) 5. Known immunodeficiency (Diagnosed primary immunodeficiency or on long-term immunosuppressants.) 6. Children with airway or facial anatomical anomalies (Choanal atresia, cleft palate, nasal trauma, craniofacial syndromes ) 7. Children with other causes of wheezing like Gastroesophageal reflux disease, airway anomalies 8. Patient who need mechanical ventilation -Children with respiratory failure (altered sensorium, gasping, apnoea) requiring emergent intubation and ventilation. 9. History of prior HFNC/NIV/MV during the same illness

Design outcomes

Primary

MeasureTime frame
Determined by decrease in PRAM by 2 points in the first 2 and 4 hours of treatmentTimepoint: Determined by decrease in PRAM by 2 points in the first 2 and 4 hours of treatment

Secondary

MeasureTime frame
1.Patients requiring escalation to 2nd line therapy for Asthma exacerbation in early use of HFNC group vs conventional oxygen therapy group 2.Duration of PICU admission 3.Duration of hospital stay 4.clinical stability in both the group by doing serial assessment of PRAM score 5.Incidence of adverse effects(e.g., pneumothorax, nasal trauma) in both groupsTimepoint: 1.From initiation of intervention(0 hour) upto 48 hours 2.From PICU admission to PICU discharge 3.From hospital admission to discharge 4.At 2,4,6,12,24,36,48 hours post intervention 5.From initiation of intervention until hospital discahrge

Countries

India

Contacts

Public ContactDr Rupayan Poddar

All India Institute of Medical Sciences ,Vijaypur

Samriti.Gupta@aiimsjammu.edu.in9418516957

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026