| CTRI Number |
CTRI/2023/11/059650 [Registered on: 08/11/2023] Trial Registered Prospectively |
| Last Modified On: |
09/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a clinical trial to compare two different interfaces RAM canula and Nasal mask for providing CPAP in preterm Infants |
|
Scientific Title of Study
|
"RAM cannula versus Nasal mask for providing Continuous positive airway pressure (CPAP) in preterm Infants. A non inferiority 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 |
Gaurav Mogra |
| Designation |
Assistant Professor |
| Affiliation |
Sri Aurobindo medical college, Indore |
| Address |
Department of Pediatrics, Sri Aurobindo Medical college, Bhanwarasala, indore
Indore
MADHYA PRADESH
453555
India |
| Phone |
9967375044 |
| Fax |
|
| Email |
drgauravmogra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gaurav Mogra |
| Designation |
Assistant Professor |
| Affiliation |
Sri Aurobindo medical college, Indore |
| Address |
Department of Pediatrics, Sri Aurobindo Medical college, Bhanwarasala, indore
MADHYA PRADESH
453555
India |
| Phone |
9967375044 |
| Fax |
|
| Email |
drgauravmogra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gaurav Mogra |
| Designation |
Assistant Professor |
| Affiliation |
Sri Aurobindo medical college, Indore |
| Address |
Department of Pediatrics, Sri Aurobindo Medical college, Bhanwarasala, indore
MADHYA PRADESH
453555
India |
| Phone |
9967375044 |
| Fax |
|
| Email |
drgauravmogra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Aurobindo medical college and PG institute, Indore |
|
|
Primary Sponsor
|
| Name |
Gaurav Mogra |
| Address |
Dept. of Pediatrics, Sri Aurobindo medical college, Indore |
| Type of Sponsor |
Other [Self] |
|
|
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 Gaurav Mogra |
Sri Aurobindo medical college and PG institure |
101, Dept. of Pediatrics, 1st floor, Hospital building
Indore
MADHYA PRADESH |
9967375044
drgauravmogra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, SAIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nasal Mask |
Nasal Mask for providing continous positive airway pressure till infant require CPAP support |
| Intervention |
RAM canula |
RAM canula for providing continous positive airway pressure till infant require CPAP support |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
preterm infants with respiratory distress within 6 hours of birth |
|
| ExclusionCriteria |
| Details |
1. Requirement of mechanical ventilation at birth
2. Major congenital malformation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CPAP failure within 72 hours |
CPAP failure within 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nasal Injury |
till discharge |
duration of CPAP & oxygen therapy
|
till discharge |
| Incidence of BPD, ROP, IVH, airleaks, NEC |
till discharge |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="98" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/11/2023 |
| Date of Study Completion (India) |
18/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Nasal Continuous positive airway pressure (CPAP)is the standard noninvasive respiratory support for preterm babies with respiratory distress.Different interfaces including binasal prongs, nasal mask and RAMcannula are used for providing CPAP to preterm infants. Nasal injuryis a common problem with the interfaces used. Nasal prongs have been used since a long time, although effective, use of binasal prongs hasbeen associated with more nasal trauma. CPAP delivered via nasal mask has been the standard of care for preterm infants with respiratory distress due to less CPAP failure and less nasal trauma. Off label use of RAM cannula is now a days very common due to ease of use and perception of decreased nasal injury. It is being used in our NICU also since long. We have observed less CPAP failure and nasal injury with RAM cannula. Also cost of RAM cannula is much less. The aim of this study is to conduct a non inferiority trial comparing effectiveness of RAM cannula versus nasal mask in preterm infants with respiratory distress.We hypothesize that RAM cannula is no inferior to nasal mask for CPAP in preterm infants. |