| CTRI Number |
CTRI/2024/07/069786 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [EFFICACY OFINDIGENOUS BUBBLE CPAP,NASAL CANNULA& HFNC,] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison between high flow nasal cannula versus indigenous bubble cpap & conventional oxygen through nasal cannula usage in moderate bronchiolitis patients to know the better modality of oxygen delivery for faster recovery of child. |
|
Scientific Title of Study
|
Efficacy of high flow nasal cannula versus indigenous bubble continuous positive airway pressure & conventional oxygen through nasal cannula in moderate bronchiolitis A Randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pradeep Reddy V |
| Designation |
Post Graduate |
| Affiliation |
sri manakula vinayagar medical collage and hospital |
| Address |
Room no49,paediatrics opd department, sri manakkula vinayagar medical collage and hospital,kalitheerthalkuppam,madagadipet,puducherry
Room no49,paediatrics opd department, sri manakkula vinayagar medical collage and hospital,kalitheerthalkuppam,madagadipet,puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9719696971 |
| Fax |
|
| Email |
jahnavepradeepreddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preethi T |
| Designation |
Associate Professor |
| Affiliation |
sri manakula vinayagar medical collage and hospital |
| Address |
Room no49,paediatrics opd department, sri manakkula vinayagar medical collage and hospital,kalitheerthalkuppam,madagadipet,puducherry
Room no49,paediatrics opd department, sri manakkula vinayagar medical collage and hospital,kalitheerthalkuppam,madagadipet,puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8879574514 |
| Fax |
|
| Email |
PREETHI.DR@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Reddy V |
| Designation |
Post Graduate |
| Affiliation |
sri manakula vinayagar medical collage and hospital |
| Address |
Room no 49,paediatrics opd department, sri manakkula vinayagar medical collage and hospital,kalitheerthalkuppam,madagadipet,puducherry
Room no 49,paediatrics opd department, sri manakkula vinayagar medical collage and hospital,kalitheerthalkuppam,madagadipet,puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9719696971 |
| Fax |
|
| Email |
jahnavepradeepreddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula Vinayagar Hospital,Room no49,paediatrics opd department,kalitheerthalkuppam, madagadipet, puducherry,India.PIN:605 107 |
|
|
Primary Sponsor
|
| Name |
Pradeep Reddy V |
| Address |
Room no49,paediatrics opd department, sri manakkula vinayagar medical collage and hospital,kalitheerthalkuppam,madagadipet,puducherry |
| Type of Sponsor |
Other [Self] |
|
|
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 Pradeep Reddy V |
sri manakkula vinayagar medical collage and hospital |
Room no49,paediatrics opd department,kalitheerthalkuppam,madagadipet,puducherrydepartment,kalitheerthalkuppam, madagadipet, puducherry,India.PIN:605 107
Pondicherry
PONDICHERRY |
9719696971
jahnavepradeepreddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri manakula vinayagar medical collage and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J219||Acute bronchiolitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Efficacy of high flow nasal cannula versus indigenous bubble continuous positive airway presure & conventional oxygen through nasal cannula in moderate bronchiolitis. |
The participants clinical condition and intervention will be explained to the parents and mode of oxygen delivery will be assigned for (Group A - HFNC) (Group B – Indigenous bubble CPAP) and (Group C – Nasal prongs). They are assessed at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr.
Infants with HFNC group will be delivered Humidified Oxygen using Fisher and Paykal HFNC machine. Children allotted into indigenous bubble CPAP group will be delivered oxygen using Chest drainage bottle 500ml with Nasal prongs, Children allotted into prongs group will be delivered oxygen using appropriate size Nasal prong cannula system connected directly.
|
| Intervention |
The participants clinical condition and intervention will be explained to the parents and mode of oxygen delivery will be assigned for (Group A - HFNC) (Group B – Indigenous bubble CPAP) and (Group C – Nasal prongs). They are assessed at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr. |
Infants with HFNC group will be delivered Humidified Oxygen using Fisher and Paykal HFNC machine. Children allotted into indigenous bubble CPAP group will be delivered oxygen using Chest drainage bottle 500ml with Nasal prongs, Children allotted into prongs group will be delivered oxygen using appropriate size Nasal prong cannula system connected directly.Cross over is possible from Group A to Group C if response is adequate. At serial reassessment if response is not adequate in group B or C, cross over will be done to group A. In worsening of symptoms and non-responders, Escalation of treatment will be proceeded to Invasive ventilation or mechanical ventilation. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
24.00 Month(s) |
| Gender |
Both |
| Details |
One month to 24 month old child
Moderate bronchiolitis
|
|
| ExclusionCriteria |
| Details |
Parents of children who refused to give consent.
Referred patients who already received HFNC outside in other hospitals and referred with complications of it.
Those with added cardiac illness
Anatomical abnormalities of respiratory tract
Moderate bronchiolitis
Other respiratory illnesses like pneumonia, pleural effusion, pyothorax.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to wean off oxygen (hrs)
Primary treatment duration (hrs)
Instances of requirement of readjustments
Grade of nasal soft tissue injury
Primary treatment failure
|
Based on socio demographic details, anthropometry, heart rate, respiratory rate, SPO2, CSS score will be recorded in the proforma at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Picu length of stay (days)
Hospital length of stay (days)
Need for invasive ventilation
|
Greater than 72hrs |
|
|
Target Sample Size
|
Total Sample Size="129"
Sample Size from India="129"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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
|
This randomized controlled open lable study will be conducted in the Department of Paediatrics, Sri Manakula Vinayagar Medical College And Hospital(SMVMCH) a tertiary care hospital in Puducherry after the approval of Research Committee and Institutional Ethics Committee .Any infant from 1month to 24 months age, who fulfill the inclusion and exclusion criteria will be included in the study after the informed and written consent is being obtained from parents. Sequential number, sealed opaque envelope will be opened by the post graduate , the child will be allotted to respective intervention group as per the block randomized list. Based on socio demographic details, anthropometry, heart rate, respiratory rate, SPO2, CSS score will be recorded in the proforma at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr. The participants clinical condition and intervention will be explained to the parents and mode of oxygen delivery will be assigned for (Group A - HFNC) (Group B – Indigenous bubble CPAP) and (Group C – Nasal prongs). They are assessed at 0 min,1hr,3hr,6hr,12hr,24hr,48hr,72hr and greater than 72hr. Infants with HFNC group will be delivered Humidified Oxygen using Fisher and Paykal HFNC machine. Children allotted into indigenous bubble CPAP group will be delivered oxygen using Chest drainage bottle 500ml with Nasal prongs, Children allotted into prongs group will be delivered oxygen using appropriate size Nasal prong cannula system connected directly. Time for resolution of underlying condition will be sequentially monitored in HFNC, indigenous bubble CPAP and prongs group and will be entered. Children labeled to have treatment failure if they have : • Hypoxia • Fio2> 60% • Retractions persists • Developing shock requiring inotrope support Cross over is possible from Group A to Group C if response is adequate. At serial reassessment if response is not adequate in group B or C, cross over will be done to group A. In worsening of symptoms and non-responders, Escalation of treatment will be proceeded to Invasive ventilation or mechanical ventilation. Nasal trauma will be classified at the point of removal . Compliance of nasal prongs, indigenous bubble CPAP and HFNC is being measured by using number of instances readjustment needed by every 2nd hourly monitoring the position of HFNC and prongs for respective group of patients. |