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CTRI Number  CTRI/2025/12/099086 [Registered on: 15/12/2025] Trial Registered Prospectively
Last Modified On: 13/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparing RAM cannula and nasal mask for non invasive breathing support in very preterm newborns  
Scientific Title of Study   RAM Cannula vs Nasal mask for delivering non invasive positive pressure ventilation in very preterm neonates an open label 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 ND Vaswani 
Designation  professor  
Affiliation  Pt BD Sharma university of health sciences Rohtak 
Address  department of paediatrics PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9034428284  
Fax    
Email  ndvaswani@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Somya Godara 
Designation  Post graduate  
Affiliation  Pt BD Sharma university of health sciences Rohtak 
Address  department of paediatrics PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9991843765  
Fax    
Email  somyagodara103@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Somya Godara 
Designation  Post graduate  
Affiliation  Pt BD Sharma university of health sciences Rohtak 
Address  department of paediatrics PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9991843765  
Fax    
Email  somyagodara103@gmail.com  
 
Source of Monetary or Material Support  
Pt BD Sharma PGIMS Rohtak 
 
Primary Sponsor  
Name  Pt BD Sharma PGIMS Rohtak 
Address  PGIMS Rohtak Haryana 124001 
Type of Sponsor  Government 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 Somya Godara  Pt BD Sharma PGIMS Rohtak  Department of Neonatology 2nd floor MCH building Pt BD Sharma PGIMS Rohtak Haryana 124001
Rohtak
HARYANA 
9991843765

somyagodara103@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical research ethics committee Pt BD Sharma PGIMS/UHS Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 5||Extracorporeal or Systemic Assistance and Performance,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nasal Mask  Nasal Masks will be used and efficacy and safety will be studied on very preterm neonates who will fulfill the criteria of receiving non invasive positive pressure ventilation as a mode of respiratory support within 2 hours of birth 
Intervention  RAM Cannula   RAM Cannula will be used and efficacy will be studied on very preterm neonates who will fulfill the criteria of receiving non invasive positive pressure ventilation as a mode of respiratory support within 2 hours of birth 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All inborn neonates fulfilling the criteria for receiving non-invasive positive pressure ventilation (NIPPV) as a mode of respiratory support within 2 hours of birth. 
 
ExclusionCriteria 
Details  Major congenital malformations, Refractory shock at the time of enrolment, Pulmonary air leaks at the time of enrolment, Consent not given by parents

 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
It will be recorded on the basis of need for intubation within hours  Participants in study will be assessed on basis of need for intubation within 72 hours after initiation of NIPPV and the criteria for intubation will be any of these on maximal settings of NIPPV that is severe respiratory distress or low SpO2 or acidotic pH or high pCO2 in blood gas or significant apneas or shock needing more than one inotrope
 
 
Secondary Outcome  
Outcome  TimePoints 
It will be recorded on basis of need of intubation within days and other late neonatal morbidities  Participants will be assessed on basis of outcomes that is need of intubation between 72 hours and 7 days after initiation of NIPPV, need for surfactant administration as per standard protocol, duration of invasive ventilation, NIPPV, and NCPAP in hours, incidence of neonatal morbidities like air leaks, BPD, IVH , NEC, incidence of feed intolerance, incidence of ROP needing treatment, Length of hospital stay.

 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   24/12/2025 
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)   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  

Non invasive positive pressure ventilation that is NIPPV is a widely used respiratory support modality in neonates, particularly in the management of respiratory distress syndrome and during post extubation care. The choice of interface plays a critical role in the effectiveness, safety, and tolerance of NIPPV. . Non invasive positive pressure ventilation is a form of non invasive respiratory support that is a combination of continuous positive airway pressure and intermittent higher pressures which are delivered via a nasal mask or nasal prongs or cannulas. The interfaces used for delivering non invasive ventilation play an important role in avoidance of intubation by determining the reduction in pressures from in the delivery circuit to those transmitted to the patient s airway. Two commonly used interfaces in neonatal care are RAM Cannula and nasal mask .Numerous studies have compared the efficacy of nasal masks versus short binasal prongs and other studies of RAM Cannula versus binasal prongs.

There are only a few studies directly comparing the efficacy of different interfaces for the delivery of NIPPV. There is limited high quality comparative data on the clinical effectiveness and complication rates of RAM Cannula vs nasal mask in neonates receiving NIPPV. This study aims to compare the effectiveness, safety and tolerance of RAM Cannula vs nasal mask in neonates requiring NIPPV, thereby guiding evidence based selection of interfaces in neonatal intensive care units.

 

 
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