| CTRI Number |
CTRI/2026/01/100176 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of RAM Cannula and nasal mask as continuous positive airway pressure interfaces |
|
Scientific Title of Study
|
A Randomised Control Study of RAM Cannula and Nasal Mask as Continuous Positive Airway Pressure Interfaces In Neonates |
| 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 R Prajna Poorna Chandra |
| Designation |
Postgraduate In Paediatrics |
| Affiliation |
Kempegowda Institute Of Medical Sciences |
| Address |
Department Of Paediatrics, Kempegowda Institute Of Medical Sciences And Research Centre, Bangalore, Karnataka, India
Bangalore
KARNATAKA
560004
India |
| Phone |
7795058996 |
| Fax |
|
| Email |
prajnapc2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish N |
| Designation |
Professor Of Paediatrics |
| Affiliation |
Kempegowda Institute Of Medical Sciences |
| Address |
Department Of Paediatrics, Kempegowda Institute Of Medical Sciences And Research Centre, Bangalore, Karnataka, India
Bangalore
KARNATAKA
560004
India |
| Phone |
9611110857 |
| Fax |
|
| Email |
drgirish79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Girish N |
| Designation |
Professor Of Paediatrics |
| Affiliation |
Kempegowda Institute Of Medical Sciences |
| Address |
Department Of Paediatrics, Kempegowda Institute Of Medical Sciences And Research Centre, Bangalore, Karnataka, India
Bangalore
KARNATAKA
560004
India |
| Phone |
9611110857 |
| Fax |
|
| Email |
drgirish79@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neonatal Intensive Care Unit, Department Of Paediatrics, Kempegowda Institute Of Medical Sciences And Research Centre, Bangalore, Karnataka, India, 560004 |
|
|
Primary Sponsor
|
| Name |
Dr R Prajna Poorna Chandra |
| Address |
Department Of Paediatrics, Kempegowda Institute Of Medical Sciences And Research Centre, Bangalore, Karnataka, India,560004 |
| 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 R Prajna Poorna Chandra |
KIMS Hospital And Research Centre , Bangalore |
Neonatal Intensive Care Unit, Department Of Paediatrics , 5TH Floor, A Block, Kempegowda Institute Of Medical Sciences And Research Centre, KR Road, Parvathi Puram , Bangalore, Karnataka, India,560004
Bangalore
KARNATAKA |
7795058996
prajnapc2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P229||Respiratory distress of newborn, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nasal Mask |
A Type Of Interface For Delivery Of Oxygen Through Continuous Positive Airway Pressure |
| Intervention |
RAM Cannula |
A Type Of Interface For Delivery Of Oxygen Through Continuous Positive Airway Pressure |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All Neonates Requiring Continuous Positive Airway Pressure (CPAP) For Respiratory Distress In NICU, Department Of Paediatrics , KIMS |
|
| ExclusionCriteria |
| Details |
Neonates With Congenital Malformations Like Choanal Atresia, Cleft Palate, Tracheo- Oesophageal Fistula, Congenital Diaphragmatic Hernia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate And Compare CPAP Failure And Need For Mechanical Ventilation With Either Of The Devices , That Is, RAM Cannula And Nasal Mask As Interface |
From birth till the total duration on CPAP |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nasal Trauma |
Over The Total Time Duration The Neonate Is On CPAP Via a Particular Interface |
| Total Duration Of CPAP Support |
Over The Total Time Duration The Neonate Is On CPAP Via A Particular Interface |
| Duration Of Supplementary Oxygen Requirement |
Total Duration Of Hospitalisation |
| Duration of Hospitalisation |
Total stay in hospital |
| Air Leaks With Each Of The Interfaces |
During total time on CPAP |
| Cross Over To Other Methods Of Non-Invasive Ventilation Or Mechanical Ventilation |
Over the total duration on CPAP |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/01/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Continuous positive airway pressure (CPAP) is the most used and scientifically evaluated non-invasive respiratory support in neonates. Various devices are used as interfaces for CPAP delivery in neonates. These include nasal prongs, nasal cannulas like Hudson, Argyle, RAM cannula and nasal masks. However, the interface used to deliver CPAP significantly affects both the therapeutic efficacy and the incidence of complications. Understanding and assessing the efficacy of the two commonly used interfaces of late, that is, RAM cannula and nasal mask for Continuous positive airway pressure (CPAP) is important for better outcomes and faster recovery. The study aims to evaluate and compare the effectiveness and outcome of RAM cannula and nasal mask as continuous positive airway pressure (CPAP) interfaces in neonates |