| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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
|
|
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Method of Generating Random Sequence
|
Stratified randomization |
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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.
|
|
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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.
|