| CTRI Number |
CTRI/2024/01/061707 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
19/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of two surfactant administration techniques |
|
Scientific Title of Study
|
Comparative evaluation of surfactant administration techniques Less Invasive Surfactant Administration (LISA) vs. Intubation Surfactant Extubation (InSurE) in Preterm Infants with Respiratory Distress Syndrome: A randomized control study |
| 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 Sukriti Amraik |
| Designation |
PG 2 year |
| Affiliation |
School of Medical Sciences and Research and Sharda Hospital |
| Address |
Department of Pediatrics, School of Medical Sciences and Research, Sharda University, Greater Noida, Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8394832263 |
| Fax |
|
| Email |
sukriti.amraik@sharda.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Kumar Thapar |
| Designation |
Head of Department, Professor |
| Affiliation |
School of Medical Sciences and Research |
| Address |
Department of Pediatrics, School of Medical Sciences and Research, Greater Noida, Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9839448248 |
| Fax |
|
| Email |
rajeev.thapar@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeev Kumar Thapar |
| Designation |
Head of Department, Professor |
| Affiliation |
School of Medical Sciences and Research |
| Address |
Department of Pediatrics, School of Medical Sciences and Research, Greater Noida, Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9839448248 |
| Fax |
|
| Email |
rajeev.thapar@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics, School of Medical Sciences and Research, Greater Noida , 201310 |
|
|
Primary Sponsor
|
| Name |
School of Medical Sciences and Research |
| Address |
Department of Pediatrics School of Medical Sciences and Research Greater Noida, 201310 |
| 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 Sukriti Amraik |
School of Medical Sciences and Research |
Department of Pediatrics, NICU, Knowledge Park III Greater Noida 201310
Gautam Buddha Nagar
UTTAR PRADESH |
8394832263
sukriti.amraik@sharda.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School of Medical Sciences AND Research & Sharda Hospital Institutional Ethics Committee |
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 |
| Comparator Agent |
Intubation Surfactant Extubation(InSurE) technique |
Preterm neonate with respiratory distress syndrome will be administered surfactant via appropriate ET tube.
Dose of surfactant will be calculated as 5ml/kg and administered in 4 aliquots over 1-2 minute. |
| Intervention |
Less Invasive Surfactant Administration (LISA) technique |
Surfactant(Neosurf) will be administered. Dose will be calculated as 5ml/kg. A 5 Fr feeding tube/Surfcath will be placed in the trachea 1–2 cm beyond vocal cords.
The surfactant (5ml/kg body weight) will be instilled in 30-60 seconds intratracheally via the catheter. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
2.00 Day(s) |
| Gender |
Both |
| Details |
Preterm infants less than 36 weeks which are fulfilling the criteria for RDS and are spontaneously breathing |
|
| ExclusionCriteria |
| Details |
Preterm neonates with
Anatomical abnormalities of upper airway Congenital Diaphragmatic hernia
Choanal atresia
Trachea-oesophageal fistula
Cleft palate
- Requiring intubation with invasive ventilation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of LISA technique over InSurE |
At 12 hours, 72 hours, throughout the study time period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need for mechanical ventilation |
within 72 hours of birth |
| need for two or more doses of surfactant |
within 12 hours of birth |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/01/2024 |
| Date of Study Completion (India) |
18/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
This study is a randomized, parallel group study aimed to do comparative evaluation of surfactant administration techniques - Less Invasive Surfactant Administration (LISA) vs Intubation Surfactant Extubation (InSurE) in preterm infants with respiratory distress syndrome. The study will be conducted in Sharda Hospital, Department of Pediatrics. The primary objective is Comparative evaluation of surfactant administration techniques - Less Invasive Surfactant Administration (LISA) vs Intubation Surfactant Extubation (InSurE) in preterm infants with respiratory distress syndrome and secondary objective is to assess the efficacy of LISA v/s InSurE through pulmonary outcomes – Need for mechanical ventilation in the first 72 hours Days on nCPAP Need for two or more doses of surfactant Length of hospital stay Bronchopulmonary Dysplasia |