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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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