A clinical trial to see which oxygen flow rate 1lt/kg/min versus 2lt/kg/min of hfnc , which work better for children who have trouble breathing

A Randomized controlled trial of heated humidified high flow nasal cannula flow of 1 lt/kg/min versus 2 lt/kg/min in management of children with moderate-severe respiratory distress - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097032

Enrollment

310

Registered

2025-11-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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 Health Condition 2: J180- Bronchopneumonia, unspecified organism Health Condition 3: J14- Pneumonia due to Hemophilus influenzae Health Condition 4: J13- Pneumonia due to Streptococcus pneumoniae Health Condition 5: J989- Respiratory disorder, unspecified Health Condition 6: J22- Unspecified acute lower respiratory infection Health Condition 7: J159- Unspecified bacterial pneumonia Health Condition 8: J129- Viral pneumonia, unspecified

Interventions

Intervention1: group A - 1lt/kg/min: children enrolled will receive hfnc at rate of 1lt/kg/min Control Intervention1: group B- 2lt/kg/min: children enrolled will receive hfnc at rate of 2lt/kg/min

Eligibility

Inclusion criteria

Inclusion criteria: with any of the following etiologies (bronchiolitis, bacterial/viral pneumonias, viral infection induced or multitriggered wheeze with respiratory distress) presenting with moderate-severe respiratory distress based on clinical respiratory score

Exclusion criteria

Exclusion criteria: children who have recieved hfnc at some other centre with hemodynamic instability requiring mechanical ventilation within 4 hours of admission those with comorbid condition such as congenital heart disease, chronic lung disease, known congenital lung or airway malformations, bronchopulmonary dysplasia , gastroesophageal reflux disease, immunodeficiency, pneumotjorax at presentation metabolic and neuromuscular diseases presenting with respiratory distress those with craniofacial anomalies or trauma

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of HFNC at 1lt/kg/min and 2lt/kg/min as assessed by failure rates with the two regimens within 24 hoursTimepoint: To compare the efficacy of HFNC at 1lt/kg/min and 2lt/kg/min as assessed by failure rates with the two regimens within 24 hours	—

Secondary

Measure	Time frame
to compare the length of icu stay between two groupsTimepoint: from admission to discharge/shift to ward;to compare time to improvement in respiratory parameters between the two groupsTimepoint: from start of hfnc , 24 hours, at time of discharge from picu/shift to ward;to compare duration of hfnc between two groupsTimepoint: from admission to discharge from picu/shift to ward;to compare the need for invasive ventilation and mortality rate between two groupsTimepoint:	—

Measure

Time frame

to compare the length of icu stay between two groupsTimepoint: from admission to discharge/shift to ward;to compare time to improvement in respiratory parameters between the two groupsTimepoint: from start of hfnc , 24 hours, at time of discharge from picu/shift to ward;to compare duration of hfnc between two groupsTimepoint: from admission to discharge from picu/shift to ward;to compare the need for invasive ventilation and mortality rate between two groupsTimepoint:

—

Countries

India

Contacts

Public ContactDr Rashmi Hooda

ESIC MCH, FARIDABAD

rashmihooda112@gmail.com9013380587

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026