| CTRI Number |
CTRI/2025/04/085863 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of respiratory distress syndrome of preterm
newborn based on Silverman Anderson score compared to standard care - a randomized control trial |
|
Scientific Title of Study
|
Management of neonatal respiratory distress syndrome on the basis of Silverman Anderson score compared to standard care- a randomized control 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 |
Avik Banerjee |
| Designation |
Postgraduate Trainee, 2nd year, Departmentof Paediatrics |
| Affiliation |
RAMAKRISHNA MISSION SEVA PRATISTHAN , VIVEKANANDA INSTITUTE OF MEDICAL SCIENCE |
| Address |
Ramakrishna Mission Seva Pratisthan
Vivekananda Institute Of Medical Science
99 Sarat Bose Road
Kolkata
WEST BENGAL
700029
India |
| Phone |
9599437339 |
| Fax |
|
| Email |
mailavikmail@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.BRAJAGOPAL RAY |
| Designation |
ASSOCIATE PROFESSOR ,DEPARTMENT OF PAEDIATRICS , |
| Affiliation |
RAMAKRISHNA MISSION SEVA PRATISTHAN , VIVEKANANDA INSTITUTE OF MEDICAL SCIENCE |
| Address |
TOWER 4
18L
SOUTH CITY
375 PRINCE ANWAR SHAH ROAD
KOLKATA
Ramakrishna Mission Seva Pratisthan
Vivekananda Institute Of Medical Science
99 Sarat Bose Road
Kolkata 700029
Kolkata
WEST BENGAL
700068
India |
| Phone |
9163371632 |
| Fax |
|
| Email |
brajaray@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
AVIK BANERJEE |
| Designation |
Postgraduate Trainee, 2nd year, Departmentof Paediatrics |
| Affiliation |
RAMAKRISHNA MISSION MISSION SEVA PRATISTHAN VIVEKANANDA INSTITUTE OF MEDICAL SCIENCE |
| Address |
88 Boys Hostel , Room no -17 ,
Ramakrishna Mission Seva Pratisthan
Vivekananda Institute Of Medical Science
99 Sarat Bose Road
Kolkata
WEST BENGAL
700026
India |
| Phone |
9599437339 |
| Fax |
|
| Email |
mailavikmail@gmail.com |
|
|
Source of Monetary or Material Support
|
| RAMAKRISHNA MISSION OF SEVA PRATISTHAN , VIVEKANANDA INSTITUTE OF MEDICAL SCIENCE ,
99 SARAT BOSE ROAD ,
KOLKATA - 700026 |
|
|
Primary Sponsor
|
| Name |
RAMAKRISHNA MISSION SEVA PRATISTHAN VIVEKANANDA INSTITUTE OF MEDICAL SCIENCE |
| Address |
RAMAKRISHNA MISSION SEVA PRATISTHAN , VIVEKANANDAINSTITUTE OF MEDICAL SCIENCE ,
99 SARAT BOSE ROAD ,
KOLKATA -700026 |
| Type of Sponsor |
Private 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 Avik Banerjee |
Ramakrishna Mission Seva Pratishthan, Kolkata |
Department of Paediatrics, 2nd Floor, Ramakrishna Mission Seva Pratishthan, Vivekananda Institute of Medical Sciences, 99 Sarat Bose Road kolkata
Kolkata
WEST BENGAL |
9599437339
mailavikmail@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, Ramakrishna Mission Seva Pratishthan, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P220||Respiratory distress syndrome of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Surfactant administration by LISA |
Surfactant to be given to premature newboorn with respiratory distress syndrome based on Silverman Anderson Score of more than 4 after validation of RDS by lung ultrasound . |
| Comparator Agent |
Surfactant will be given by INSURE method |
Newborn babies in this group will be given surfactant by INSURE method using criteria of standard care of the unit. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
3.00 Day(s) |
| Gender |
Both |
| Details |
1 . Gestational age of 28+0 to 34+6 Weeks
2 . Haemodynamically stable
3 . No visible congenital anomaly
4 . Inborn babies |
|
| ExclusionCriteria |
| Details |
1 . Gestational age below 28 weeks or above 35 weeks
2 . Haemodynamically unstable
3 . Any congenital anamoly
4 . Pneumothorax
5 . Intubated newborn since birth |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Total duration of oxygen therapy in the two groups
|
When respiratory support is withdrawn after 1 week after admission and at transfer out / discharge from unit
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mortality in two groups
2. Total duration of NICU stay
3. Requirement of ventilatory support in two groups
|
AT 1 WEEK FROM ADMISIION ANDTRANSFER OT/ DISCHARGE FROM UNIT |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/05/2025 |
| 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="0"
Months="6"
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
|
STUDY WILL RECRUIT PRETERM NEWBORNS WITH RESPIRATORY DISTRESS SYNDROME . RECRUITS WILL BE ASIGNED INTO EITHER CONTROL OR TRIAL GROUP BY RANDOMIZATION . IN THE TRIAL GROUP SURFACTANT WILL BE ADMINISTERED USING A INFANT FEEDING TUBE . IN THE CONTROL GROUP SURFACTANT WILL BE ADMINISTERED BY INSURE METHOD . BOTH GROUP RDS WILL BE VALIDATED BY POINT OF CARE ULTRASOUND OF THE LUNGS AND PNEUMOTHORAX RULED OUT . DATA WILL BE COLLECTED AND ANALYSED FOR OUTCOME VARIABLES AND WHETERTHEY ARE SIGNIFICANT . . |