| 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 |
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Public Title of Study
|
Comparison of Ram cannula and short binasal prongs in delivering CPAP |
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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 |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
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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 |
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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 |
|
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Source of Monetary or Material Support
|
| Institute of Obstetrics and Gynecology, Madras medical College |
|
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Primary Sponsor
|
| Name |
Richa Singh Rajawat |
| Address |
Department of Neonatalogy, Institute of Obstetrics and Gynecology, Madras medical College, Chennai
|
| Type of Sponsor |
Other [Self ] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Madras medical College |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
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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. |
|
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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
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Method of Generating Random Sequence
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Stratified block randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Open Label |
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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 |
|
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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 |
|
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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 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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