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CTRI Number  CTRI/2023/05/052972 [Registered on: 22/05/2023] Trial Registered Prospectively
Last Modified On: 19/05/2023
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 Ram cannula and short binasal prongs in delivering CPAP  
Scientific Title of Study   Comparison of Ram cannula and short binasal prongs in delivering CPAP on targeting mean oropharyngeal pressures - A randomised non-inferiority trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Richa Singh Rajawat 
Designation  Senior resident 
Affiliation  Madras medical College  
Address  Department of Neonatalogy, Institute of Obstetrics and Gynecology Madras medical College
A2, CEEBROS NAFEESA TOWER, HALLS ROAD, Egmore Chennai Pin code 600008
Chennai
TAMIL NADU
600008
India 
Phone  9870320571  
Fax    
Email  richarajawat@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mangala bharathi 
Designation  Professor and Head of Department of Neonatalogy  
Affiliation  Madras medical College  
Address  Department of Neonatalogy, Institute of Obstetrics and Gynecology Madras medical College

Chennai
TAMIL NADU
600008
India 
Phone  9840786836  
Fax    
Email  drmangalabharathi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mangala bharathi 
Designation  Professor and Head of Department of Neonatalogy  
Affiliation  Madras medical College  
Address  Department of Neonatalogy, Institute of Obstetrics and Gynecology Madras medical College

Chennai
TAMIL NADU
600008
India 
Phone  9840786836  
Fax    
Email  drmangalabharathi@gmail.com  
 
Source of Monetary or Material Support  
Institute of Obstetrics and Gynecology, Madras medical College  
 
Primary Sponsor  
Name  Richa Singh Rajawat  
Address  Department of Neonatalogy, Institute of Obstetrics and Gynecology, Madras medical College, Chennai  
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 
Mangala bharathi   Institute of Obstetrics and Gynecology and Government hospital for women and children   Department of Neonatalogy, Institute of Obstetrics and Gynecology,Madras medical College, Pantheon road, Egmore, Chennai
Chennai
TAMIL NADU 
9840786836

drmangalabharathi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee , Madras medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ram cannula targeting mean oropharyngeal pressures  Baby will be provided CPAP with Ram cannula targeting mean oropharyngeal pressures and pressures will be measured at 0,12,24 hours of starting CPAP. CPAP failure will be assessed within 72 hours of randomisation. 
Comparator Agent  Short Binasal prongs targeting mean oropharyngeal pressures   Baby will be provided CPAP with short Binasal prongs targeting mean oropharyngeal pressures and pressures will be measured at 0,12,24 hours of starting CPAP. CPAP failure will be assessed within 72 hours of randomisation. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Day(s)
Gender  Both 
Details  Any neonate 28-≤35 weeks gestation requiring NICU admission for respiratory distress within 6 hours of life (28-≤32 weeks & 32-≤35weeks), Fio2 requirement <40% 
 
ExclusionCriteria 
Details  Major congenital malformation
Birth asphyxi
Encephalopathy
Shock
Need for intubation in first 6 hours of life
Poor spontaneous respiratory efforts
Denial of consent
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy in Ram cannula and short binasal prongs group by assessing duration of CPAP in preterm neonates (28-≤35 weeks) with respiratory distress managed on bubble CPAP as primary respiratory support targeting the mean delivered oropharyngeal pressures.  Mean oropharyngeal pressures will be measured at 0, 12, 24 hours of starting CPAP support 
 
Secondary Outcome  
Outcome  TimePoints 
1. CPAP failure (Need for change of interface / escalation of respiratory support within 72 hours of randomization)
2. Nasal trauma
3. All-cause mortality till discharge
4. Surfactant requirement
5. Air leaks
6. NEC
7. ROP requiring treatment
8. Duration of NICU stay
9. Duration of hospital stay
 
At end of 72 hours 
 
Target Sample Size   Total Sample Size="98"
Sample Size from India="98" 
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)   29/05/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Respiratory distress is one of the commonest problems in neonatal period which warrants NICU admission. Nasal continuous positive airway pressure (nCPAP) is the most frequent modality used to prevent respiratory failure, mechanical ventilation use and mortality. Use of CPAP in preterm infants helps in reduction in respiratory failure, need of mechanical ventilation and mortality. [1]
Nasal interface plays a very important role in nCPAP delivery. It should be easy to use and should deliver required CPAP pressures without causing any nasal trauma. Various interfaces available are nasopharyngeal tubes, short binasal prongs and nasal masks. Despite being inferior to nasal masks in CPAP delivery, short binasal prongs are one of the most commonly used nasal interfaces in delivering nasal CPAP due to their user-friendliness and easy availability. [2]
RAM cannula (Neotech, Valencia, CA) is FDA-approved for oxygen therapy but it’s off-label use in CPAP and NIPPV delivery is getting popular day by day. As it is made up of soft material and has an adapter attached to it, thus helps to reduce nasal injury, improve neonatal comfort, and helps in easy transition from NIPPV to CPAP support without changing interface. [3,4] Simulation studies have shown that Ram cannula leads to suboptimal pressure transmission, which may be ineffective in delivering CPAP if leak from the nostrils exceeds certain threshold margin. [5-9]
2. REVIEW OF LITERATURE :
As Ram cannula is gaining popularity as a newer mode of nasal interface to provide CPAP as well as NIPPV support, not much literature exists to provide evidence regarding failure rates of nasal CPAP delivery.
Previous studies were successful in showing that Ram cannula provides consistently lower set delivered oropharyngeal pressures as compared to short binasal prongs. [8,10] There is lot of ambiguity in results published regarding clinical outcomes such as need of invasive ventilation and failure rates of CPAP and NIPPV support. [4-9]
Studies till date have used barrier dressing on nasal septum to prevent nasal injuries, but mostly cannulaide have been used for either group, resulting in bias. [4,5,12,13] None of the studies have used cannulaide for both comparison groups in delivering nasal CPAP.
One of the latest non-inferiority randomized controlled trial comparing Ram cannula with Hudson prongs in preterm neonates admitted for respiratory distress was not able to prove the non-inferiority of Ram cannula with short binasal prongs. The study was underpowered due to small sample size and did not measure mean oropharyngeal pressures. [13]
A recent systematic review and meta-analysis showed no difference in nasal injury rates and concluded that no clinical benefit or harm can be ruled out for outcome of need of invasive mechanical ventilation and need for surfactant, and adequately powered studies are needed to evaluate the efficacy of Ram cannula compared with other interfaces. [11]
JUSTIFICATION:
Ram cannula is superior in preventing nasal injuries in neonates but delivers less oropharyngeal pressures. Previous studies have used cannulaide either for Ram cannula or Hudson for comparison of nasal trauma and leak, resulting in bias. So far none of the studies have reported the efficacy of Ram cannula in delivering CPAP by targeting delivered mean oropharyngeal pressures. We hypothesize that Ram cannula is non inferior to short binasal prongs if delivered mean oropharyngeal pressures are targeted.

 
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