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two different methods of giving oxygen treatment in children with moderate to severe acute bronchiolitis

Efficacy of indigenous nasal prong continuous positive airway pressure and high flow nasal cannula in children with moderate to severe bronchiolitis - A open labelled randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/020402
Enrollment
124
Registered
2019-07-29
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: J219- Acute bronchiolitis, unspecified

Interventions

Intervention1: Humidified, Heated, High flow nasal cannula HHHFNC therapy: HFNC is commenced at 2 perkgpermin, and fraction of inspired oxygen was titrated to oxygen saturation more than 94%. Accordin

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children aged one-month (corrected) to 23-month with clinical diagnosis of moderate to severe bronchiolitis [Bronchiolitis will be defined as respiratory distress with wheezing or crackles on auscultation and modified Wood’s clinical asthma score =4]

Exclusion criteria

Exclusion criteria: 1. Children who are in need of imminent mechanical ventilator support. 2. Children with suspected / known heart disease. 3. Children with suspected / known chronic lung disease. 4. Children with suspected / known diagnosis of neuromuscular disease. 5. Children hospitalized for respiratory illness in last one-month period. 6. Children with facial malformations. 7. Children with severe malnutrition [weight for age

Design outcomes

Primary

MeasureTime frame
To compare the success rates of high flow nasal cannula and indigenous nasal prong continuous positive airway pressure in the management of children with moderate to severe bronchiolitis within 24-hours of randomization.Timepoint: 24 hours—

Secondary

MeasureTime frame
5. To compare the factor(s) associated with failure.Timepoint: 24 hours and hospital stay;6. To compare the serious adverse events (air leak syndrome, apnea, death).Timepoint: 24 hours and hospital stay;1. To compare the success rate after cross over of the intervention(s).Timepoint: 24 hours and Hospital Stay;2. To compare the need for mechanical ventilation (non-invasive or invasive).Timepoint: 24 hours and hospital stay;3. To compare the local skin lesions associated with application of interface. (skin lesion will be assessed as per “National Pressure Ulcer Advisory Panel definitions ?)Timepoint: 24 hours and hospital stay;4. To compare the length of hospital stay including pediatric intensive care unit stay.Timepoint: 24 hours and hospital stay—

Countries

India

Contacts

Public ContactDr Tamil Selvan

JIPMER

drselvantg@yahoo.com9916485716

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026