| CTRI Number |
CTRI/2025/11/097032 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Umang |
| Designation |
Post Graduate Resident |
| Affiliation |
ESIC MCH, FARIDABAD |
| Address |
Department of Paediatrics, 8th floor, ESIC Medical College And HOSPITAL, FARIDABAD
Faridabad
HARYANA
121001
India |
| Phone |
8053480168 |
| Fax |
|
| Email |
umanggoel6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Hooda |
| Designation |
Assistant Professor |
| Affiliation |
ESIC MCH, FARIDABAD |
| Address |
Department of Paediatrics, 8th floor ESIC Medical College And HOSPITAL, FARIDABAD
Faridabad
HARYANA
121001
India |
| Phone |
9013380587 |
| Fax |
|
| Email |
rashmihooda112@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Hooda |
| Designation |
Assistant Professor |
| Affiliation |
ESIC MCH, FARIDABAD |
| Address |
Department of Paediatrics, 8th floor, ESIC Medical College And HOSPITAL, FARIDABAD
Faridabad
HARYANA
121001
India |
| Phone |
9013380587 |
| Fax |
|
| Email |
rashmihooda112@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC medical college and hospital, Faridabad, Haryana, India, 121001 |
|
|
Primary Sponsor
|
| Name |
ESIC medical college and hospital |
| Address |
Faridabad, Haryana, India, 121001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Umang |
ESIC MCH , FARIDABAD |
PICU, Department of Paediatrics, 8TH Floor, FARIDABAD, HARYANA
Faridabad
HARYANA |
8053480168
umanggoel6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J219||Acute bronchiolitis, unspecified, (2) ICD-10 Condition: J180||Bronchopneumonia, unspecified organism, (3) ICD-10 Condition: J14||Pneumonia due to Hemophilus influenzae, (4) ICD-10 Condition: J13||Pneumonia due to Streptococcus pneumoniae, (5) ICD-10 Condition: J989||Respiratory disorder, unspecified, (6) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, (7) ICD-10 Condition: J159||Unspecified bacterial pneumonia, (8) ICD-10 Condition: J129||Viral pneumonia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group A - 1lt/kg/min |
children enrolled will receive hfnc at rate of 1lt/kg/min |
| Comparator Agent |
group B- 2lt/kg/min |
children enrolled will receive hfnc at rate of 2lt/kg/min |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
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 Outcome
|
| Outcome |
TimePoints |
| to compare the length of icu stay between two groups |
from admission to discharge/shift to ward |
| to compare time to improvement in respiratory parameters between the two groups |
from start of hfnc , 24 hours, at time of discharge from picu/shift to ward |
| to compare duration of hfnc between two groups |
from admission to discharge from picu/shift to ward |
| to compare the need for invasive ventilation and mortality rate between two groups |
|
|
|
Target Sample Size
|
Total Sample Size="310"
Sample Size from India="310"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Acute respiratory illnesses affect children worldwide but the incidence of severe ARI is highest in Africa and Southeastern Asia. these illness result in respiratory distress and poor feeding necessitating hospital admission. the provision of respiratory support in children with moderate to severe respiratory distress necessitates the use of supplemental oxygen to hypoxemic children and respiratory support in forM of CPAP, HFNC, NIV or invasive ventilation. HFNC provides heated humidified oxygen at high flows, reduces nasopharyngeal dead space, leads to CO2 washout and PEEP leading to improvement in parenchymal as well as airway diseases. the use of HFNC in paediatric practice has been studied in acute viral bronchiolitis , asthma, pneumonia, post extubation and in respiratory failure to avert the need for invasive ventilation. so far, there are only 3 rct to study the impact of initial flow rate on failure rate in children, all of which focus on infants and children less than 2 years of age with bronchiolitis. there is no rct on effect of flow rate in older children and with indications other than bronchiolitis. so, we decided to conduct this study on the flow settings of hfnc in children less than 5 years of age with moderate to severe respiratory distress. |