Comparing the effectiveness, safety and cost of high flow oxygen and standard (low flow) oxygen in infants with bronchiolitis

Randomized controlled parallel arm clinical trial comparing the effectiveness, safety and cost of humidified high flow nasal cannula oxygen therapy and conventional (low flow) oxygen therapy in infants with moderate bronchiolitis

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2017/017

Enrollment

Unknown

Registered

2017-06-22

Start date

2017-07-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Bronchiolitis

Interventions

Study setting: Professorial Paediatric Unit, Teaching Hospital Jaffna, Sri Lanka. Method of Randomization: Single center balanced randomized [1:1], two arm parallel group clinical trial design. A re

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female infants (less than 1 year of age) 2. Clinically diagnosed to have moderate bronchiolitis (RADI score of 4 or above) 3. Oxygen saturation in air is less than 94% 4. Receiving in ward treatment

Exclusion criteria

Exclusion criteria: 1. Infants admitted directly to the intensive care unit (ICU) 2. Infants with upper airway abnormalities 3. Infants with congenital heart disease or neuromuscular anomalies 4. Infants with diagnosed immune deficiency 5. Infants with chronic lung disease such as bronchiolitis obliterans

Design outcomes

Primary

Measure	Time frame
Need for paediatric intensive care unit (PICU) admission and intubation [30 minutes after intervention and then • Hourly for 2 hours • 2 hourly for 4 hours • 4 hourly until completion of 24 hours after initiation of treatment • 8 hourly until completion 48 hours after initiation of treatment]	—

Secondary

Measure	Time frame
Improvement in the heart rate, respiratory rate [Assessed at: 30 minutes after intervention and then • Hourly for 2 hours • 2 hourly for 4 hours • 4 hourly until completion of 24 hours after initiation of treatment • 8 hourly until completion 48 hours after initiation of treatment] Improvement in respiratory distress assessment instrument (RADI) scores. [Assessed at: 30 minutes after intervention and then • Hourly for 2 hours • 2 hourly for 4 hours • 4 hourly until completion of 24 hours after initiation of treatment • 8 hourly until completion 48 hours after initiation of treatment] Mean oxygen saturation. [Assessed at: 30 minutes after intervention and then • Hourly for 2 hours • 2 hourly for 4 hours • 4 hourly until completion of 24 hours after initiation of treatment • 8 hourly until completion 48 hours after initiation of treatment] Number of hours requiring oxygen [At discharge] Duration of hospital stay [At discharge ] Cost of the treatment (based on calculations by Senanayake et al, 2012 and Thalagala et al, 2016) [At discharge] Adverse effects of humidified high flow nasal cannula oxygen i. Skin irritation at the site of nasal cannula ii. Nasal bleeding iii. Abdominal/gastric distention iv. Feed intolerance v. Pneumothorax vi. Pneumomediastinum vii. Subcutaneous emphysema [Adverse effects of humidified high flow nasal cannula oxygen Assessed at: 30 minutes after intervention and then • Hourly for 2 hours • 2 hourly for 4 hours • 4 hourly until completion of 24 hours after initiation of treatment • 8 hourly until completion 48 hours after initiation of treatment • At discharge]	—

Measure

Time frame

Improvement in the heart rate, respiratory rate [Assessed at: 30 minutes after intervention and then • Hourly for 2 hours • 2 hourly for 4 hours • 4 hourly until completion of 24 hours after initiation of treatment • 8 hourly until completion 48 hours after initiation of treatment] Improvement in respiratory distress assessment instrument (RADI) scores. [Assessed at: 30 minutes after intervention and then • Hourly for 2 hours • 2 hourly for 4 hours • 4 hourly until completion of 24 hours after initiation of treatment • 8 hourly until completion 48 hours after initiation of treatment] Mean oxygen saturation. [Assessed at: 30 minutes after intervention and then • Hourly for 2 hours • 2 hourly for 4 hours • 4 hourly until completion of 24 hours after initiation of treatment • 8 hourly until completion 48 hours after initiation of treatment] Number of hours requiring oxygen [At discharge] Duration of hospital stay [At discharge ] Cost of the treatment (based on calculations by Senanayake et al, 2012 and Thalagala et al, 2016) [At discharge] Adverse effects of humidified high flow nasal cannula oxygen i. Skin irritation at the site of nasal cannula ii. Nasal bleeding iii. Abdominal/gastric distention iv. Feed intolerance v. Pneumothorax vi. Pneumomediastinum vii. Subcutaneous emphysema [Adverse effects of humidified high flow nasal cannula oxygen Assessed at: 30 minutes after intervention and then • Hourly for 2 hours • 2 hourly for 4 hours • 4 hourly until completion of 24 hours after initiation of treatment • 8 hourly until completion 48 hours after initiation of treatment • At discharge]

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Countries

Sri Lanka

Contacts

Public ContactDr. N. Umasankar

Lecturer

unirubaa@yahoo.comTel: 0212220378

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026