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CTRI Number  CTRI/2024/06/068826 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 09/06/2024
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 RAMS cannula and nasal mask as interface for delivery of nasal continuous positive pressure pressure in preterm neonates 
Scientific Title of Study   Nasal continuous positive airway pressure with RAM cannula versus nasal mask in reducing the need for invasive mechanical ventilation in preterm 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 Nikhil Srivastav 
Designation  Post Graduate Resident, Department of Paediatrics 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 
Address  H block, Department of Paediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029

South
DELHI
110029
India 
Phone  9005792082  
Fax    
Email  nikhilsrivastav201@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep Kumar Debata 
Designation  Professor, Department of Paediatrics 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 
Address  H block, 2nd floor, Department of Paediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029

South
DELHI
110029
India 
Phone  7291000664  
Fax    
Email  drpkdebata@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep Kumar Debata 
Designation  Professor, Department of Paediatrics 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 
Address  H block, 2nd floor, Department of Paediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029

South
DELHI
110029
India 
Phone  7291000664  
Fax    
Email  drpkdebata@gmail.com  
 
Source of Monetary or Material Support  
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 
 
Primary Sponsor  
Name  Dr Nikhil Srivastav 
Address  Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 
Type of Sponsor  Other [Self] 
 
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 Nikhil Srivastav  Safdarjung Hospital  Neonatalogy intensive care unit, Department of Paediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029
South
DELHI 		 9005792082

nikhilsrivastav201@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee VMMC and Safdarjung Hospital  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  Nasal Mask  Fisher & Paykel Nasal mask will be used for delivering nCPAP (nasal continuous positive airway pressure) Duration 18 months 
Intervention  RAM Cannula  RAM cannula (Neotech products, INC, Valencia USA) is a FDA approved binasal prong used as interface for delivering nCPAP (nasal continuous positive airway pressure). Duration 18 months 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  3.00 Day(s)
Gender  Both 
Details  Inborn preterm neonates less than 34 weeks of gestation with respiratory distress syndrome within 6 hours of life 
 
ExclusionCriteria 
Details  Major congenital malformation, including chromosomal anomalies, which interfere with respiration or putting the newborn on nCPAP and severe perinatal asphyxia with 5 min Apgar score less than 3 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Need for invasive mechanical ventilation within 72 hours of nCPAP application   72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence and severity of Nasal trauma  72 hours 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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 3 
Date of First Enrollment (India)   01/07/2024 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nikhilsrivastav201@gmail.com].

  6. For how long will this data be available start date provided 15-01-2026 and end date provided 15-01-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Following thesis is on comparing nasal interface RAM cannula and nasal mask for application of nasal continuous positive airway pressure (nCPAP) in preterm neonates less than 34 weeks of gestation with respiratory distress within 6 hours of life. nCPAP is a type of non invasive ventilation. Both these interfaces are currently in use in our institute in neonatal intensive care unit. This thesis is about comparing both the interfaces about their failure rate and neonantes requiring invasive mechanical ventilation as primary objective and secondary objective is incidence of nasal trauma in both the interfaces. Inclusion criteria will be all inborn neonates with gestation age less than 34 weeks having respiratory distress syndrome within 6 hours of life. Each neonate will be given nCPAP via RAM cannula or nasal mask and will be followed for 72 hours of life. Exclusion criteria will be major congenital malformations, including chromosomal anomalies, which interfere with respiration or putting the newborn on nCPAP and severe perinatal birth asphyxia with 5 min Apgar score less than 3. 
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