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Comparison of Two Methods for Weaning High Flow Oxygen Therapy in Young children: A Randomised study

Holiday vs Flow weaning strategies for Discontinuation of High Flow Nasal Cannula Therapy in Children under 5 years with respiratory distress in a tertiary care hospital: Open label, Randomized Control Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108453
Enrollment
60
Registered
2026-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: J22- Unspecified acute lower respiratory infection

Interventions

Intervention1: HOLIDAY METHOD: Children aged 1 59 months with respiratory distress, will be screened for initiation of HFNC therapy based on Clinical Respiratory Distress Score (CRS) more than or equa

Sponsors

MADHUSUDAN S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age from 1 month to 5 years. 2. Initiated on HFNC for acute respiratory distress/failure. 3. Diagnosed with Bronchiolitis or Pneumonia or viral triggered wheeze. 4. The treating clinician considers the patient ready for weaning. 5. Informed consent obtained from legal guardian.

Exclusion criteria

Exclusion criteria: 1. Post extubation 2. Escalation to NIV/IMV before weaning 3. Persistent Pneumonia 4. Empyema 5. Asthma 6. Congenital/Acquired heart disease 7. Chronic Lung disease(Bronchopulmonary dysplasia, Cystic fibrosis, Primary Ciliary Dyskinesia, Congenital lung malformation, Bronchiectasis) 8. Congestive cardiac failure 9. Chronic neurological/neuromuscular disease 10. Chronic kidney disease 11. Airway anomaly/malacia 12. Malignancy/Post transplant/Immunocompromised 13. Home-ventilation/oxygen dependence. 14. Refusal to consent

Design outcomes

Primary

MeasureTime frame
To compare length of PICU stayTimepoint: Till PICU discharge or transfer out to ward or death

Secondary

MeasureTime frame
To compare duration of HFNC therapy in hours from initiation of weaning to transition to standard oxygen therapy.Timepoint: Time points from weaning to transition to standard oxygen therapy;To compare duration of total HFNC useTimepoint: Time from initiation to stopping of HFNC;To compare length of hospital stayTimepoint: Till hospital discharge or death;To compare rate of weaning failure, that is, re-initiation of HFNC or escalation to non-invasive ventilation or invasive mechanical ventilation within 24 hours post weaning attempt.Timepoint: 24 hours post weaning attempt;To compare time from initiation of weaning to weaning failure.Timepoint: Till the time of weaning failure , that is re-initiation of HFNC or escalation to non invasive or invasive mechanical ventilation;To assess safety outcomesTimepoint: Whole study period especially during the time of HFNC theray;To compare mean oxygen consumption between the two groups that is HFNC flow multiplied by hoursTimepoint: From initiation to stopping of HFNC

Countries

India

Contacts

Public ContactAnanya Shriyam

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BIBINAGAR

madhu_1511@yahoo.com8019111960

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026