| CTRI Number |
CTRI/2026/02/103932 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two nasal cannulas for giving non-invasive breathing support in preterm babies |
|
Scientific Title of Study
|
Comparison of Different Types of Cannula with Long and Narrow Tubing (CLNT) in the Administration of Non-Invasive Ventilation (NIV) in Preterm Neonates: An Exploratory 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 |
Dr. Patlolla Shanti |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Neonatology,
Kasturba Medical College, Manipal Department of Neonatology,
Kasturba Medical College, Manipal Udupi KARNATAKA 576104 India |
| Phone |
8790977767 |
| Fax |
|
| Email |
Patlolla.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Patlolla Shanti |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Neonatology,
Kasturba Medical College, Manipal Department of Neonatology,
Kasturba Medical College, Manipal Udupi KARNATAKA 576104 India |
| Phone |
8790977767 |
| Fax |
|
| Email |
Patlolla.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr. Patlolla Shanti |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Neonatology,
Kasturba Medical College, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
8790977767 |
| Fax |
|
| Email |
Patlolla.kmcmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KASTURBA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF NEONATOLOGY
KASTURBA MEDICAL COLLEGE
MANIPAL, KARNATAKA,576104 |
| Type of Sponsor |
Private 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 Patlolla Shanti |
Kasturba Medical College, Manipal |
Department of Neonatology
1st Floor
Women and Child Block Udupi KARNATAKA |
8790977767
Patlolla.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College and Kasturba Hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P220||Respiratory distress syndrome of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CLNT F TYPE - Fischer and Paykel Optiflow Junior Cannula |
Non-invasive ventilation (CPAP/NIPPV) delivered using Optiflow Junior nasal cannula as primary respiratory support in preterm neonates with respiratory distress for 18 months. |
| Intervention |
CLNT R TYPE - RAM Canunula |
Non Invasive ventilation (CPAP/NIPPV) delivered using RAM nasal cannula as primary respiratory support in preterm neonates with respiratory distress for 18 months |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Preterm neonates with birth weight more than 1000 gm for whom Non Invasive Ventilation (NIV) is being initiated as primary non-invasive respiratory support soon after birth |
|
| ExclusionCriteria |
| Details |
1)Neonates with major congenital malformations/orofacial anomalies/ suspected chromosomal anomaly
2)Extramural babies |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Failure of Non Invasive Ventilation |
within 72 hours after initiation of Non-invasive Ventilation (NIV)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment failure rates after 72 hours. |
72 hours till discharge |
Effectiveness of pressure delivery with different CLNTs as assessed by number of adjustments of cannula needed in a day
|
Within the first 72 hours |
| Incidence and severity of nasal injury |
During hospital stay |
| Ease of use and handling of the device by nursing staff |
During hospital stay |
| Requirement of surfactant therapy |
During hospital stay |
| Complications of prematurity including bronchopulmonary dysplasia, hemodynamically significant patent ductus arteriosus, necrotizing enterocolitis, culture positive sepsis, ventilator associated pneumonia, intraventricular hemorrhage, and retinopathy of prematurity requiring treatment |
During hospital stay |
| Occurrence of air leak syndromes |
During hospital stay |
| Duration of invasive and non invasive respiratory support |
During hospital stay |
| Time taken to achieve full enteral feeds |
During hospital stay |
| Length of hospital stay |
Up to discharge |
| Overall mortality |
During hospital stay |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
02/03/2026 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study is an exploratory randomized controlled trial conducted in the neonatal intensive care unit to compare the safety and efficacy of different cannula with long and narrow tubing interfaces for delivery of non invasive ventilation in preterm neonates. Preterm neonates with birth weight more than 1000 grams who require non invasive ventilation as primary respiratory support will be enrolled after obtaining informed consent. Eligible neonates will be randomized to receive non invasive ventilation using either RAM cannula or Optiflow Junior nasal cannula. Both groups will be managed according to standard NICU protocols. The primary outcome is non invasive ventilation failure within 72 hours of initiation. Secondary outcomes include treatment failure after 72 hours, effectiveness of pressure delivery, incidence and severity of nasal injury, ease of use of the interface by nursing staff, need for surfactant, complications of prematurity, duration of respiratory support, length of hospital stay, and mortality before discharge. The study aims to generate pilot data comparing two commonly used cannula interfaces and to guide future larger multicenter trials and standardization of interface selection in neonatal intensive care units.
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