| CTRI Number |
CTRI/2026/02/103767 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Two Ways to Help Preterm Babies Breathe: A Study Comparing RAM Cannula and Nasal Mask |
|
Scientific Title of Study
|
Efficacy of RAM Cannula vs Nasal Mask as an Interface in Primary Respiratory Support with Non-Invasive Positive Pressure Ventilation(NIPPV) in Preterm Infants (28–36 weeks GA) with Respiratory Distress – A Randomised 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 |
Dr Bijan Saha |
| Designation |
Professor and HOD |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Department of Neonatology IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata
West Bengal
India
Third floor Department of Neonatology IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata
West Bengal
700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9051389120 |
| Fax |
|
| Email |
bijansaha18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bijan Saha |
| Designation |
Professor and HOD |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Department of Neonatology IPGMER AND SSKM Hospital 244 AJC Bose Road Kolkata
Third floor Department of Neonatology IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata
WEST BENGAL
Pin 700020
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
9051389120 |
| Fax |
|
| Email |
bijansaha18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saugata Chaudhuri |
| Designation |
Assistant Professor |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Department of Neonatology IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata
India
Third floor Department of Neoatology IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata
West Bengal
700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9477036563 |
| Fax |
|
| Email |
saugata.dr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Postgraduate Medical Education and Research, Kolkata |
|
|
Primary Sponsor
|
| Name |
Institute of Postgraduate Medical Education and Research, Kolkata |
| Address |
Department of Neonatology, Division- Neonatal Intensive Care Unit, Room no.1, 244 AJC Bose Road, PS-Bhowanipore
Kolkata
WEST BENGAL
700020
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 BIJAN SAHA |
Institute of Post Graduate Medical Education and Research |
Department on Neonatology, Division- Neonatal Intensive Care Unit, Room no.1,244 AJC Bose Road, PS-Bhowanipore, Kolkata
WEST BENGAL
Kolkata
WEST BENGAL |
9051389120
bijansaha18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER RESEARCH OVERSIGHT COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nasal mask |
During NIPPV of respiratory support with RAM cannula initial PIP will be at 12 to 14 cm of water and PEEP of 4 to 6 cm of water and fraction of inspired oxygen will be adjusted to maintain saturation between 90 to 95 percent.in case of desaturation PIP will be increased upto 25cm of water with simulatneous increase in PEEP upto 6cm of water and fraction of inspired oxygen upto 60 percent to maintain target saturation.Beyond that, the intervention will be considered to have failed ventilator and the babies will be intubated. |
| Intervention |
RAM Cannula |
During NIPPV of respiratory support with RAM cannula initial PIP will be at 12 to 14 cm of water and PEEP of 4 to 6 cm of water and fraction of inspired oxygen will be adjusted to maintain saturation between 90 to 95 percent.in case of desaturation PIP will be increased upto 25cm of water with simulatneous increase in PEEP upto 6cm of water and fraction of inspired oxygen upto 60 percent to maintain target saturation.Beyond that, the intervention will be considered to have failed ventilator and the babies will be either have a trial with a nasal mask interface (cross-over)or will be directly intubated. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
3.00 Day(s) |
| Gender |
Both |
| Details |
1. Infants born more or equal 28 weeks of gestation
2. Inborn babies up to postnatal age 72 hours
3. Evidence of respiratory distress (SAS Score more than 3)
|
|
| ExclusionCriteria |
| Details |
1. Babies lesss than 28 weeks of gestational age at birth
2. Outborn babies
3. Major congenital anomalies or known/suspected chromosomal anomalies
4. Upper airway anomalies
5. Severe perinatal asphyxia (blood gas pH less than 7.0 and BE more than-12)
6. Participation in another randomized interventional trial
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Treatment failure |
Within 72 hours of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Bronchopulmonary dysplasia (BPD)
2. Mortality (all causes within NICU stay/ upto 28 days)
3. Invasive ventilator days
4. Invasive Ventilator-free days
5. Necrotizing enterocolitis (Stage 2 and above)
6. Late onset sepsis (only blood culture proven)
7. Gastrointestinal perforation (confirmed on roentgenogram or surgical exploration)
8. Pulmonary air leak, including pulmonary interstitial emphysema (PIE), pneumomediastinum and pneumothorax.
9. Intraventricular haemorrhage on cranial ultrasound, grade 3 and above
10. Feed intolerance
|
Till discharge |
|
|
Target Sample Size
|
Total Sample Size="246"
Sample Size from India="246"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/03/2026 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 effectiveness of non-invasive ventilation is largely influenced by the interface used for pressure delivery. Commonly used interfaces include short binasal prongs and nasal masks . Randomised trials and systematic reviews have shown that nasal masks are associated with reduced air leaks, better pressure transmission, and lower incidence of nasal injury compared to prongs. However, both interfaces may still cause complications such as septal trauma and discomfort, limiting their long-term use.This will be a prospective, randomized control, single-centre, clinical trial comparing the effectiveness of Ram cannula vs Nasal mask as an interface in primary respiratory support with NIPPV in preterm infants (28-36 weeks GA) with respiratory distress. Informed consent from parents will be taken.Outcomes as described will be noted from time to time. In case of failure in any mode, babies will be managed accordingly. |