CTRI Number |
CTRI/2023/07/054608 [Registered on: 03/07/2023] Trial Registered Prospectively |
Last Modified On: |
02/07/2023 |
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 surfactant delivery methods - Endotracheal tube vs Laryngeal mask airway |
Scientific Title of Study
|
Efficacy of Surfactant administration through laryngeal or supraglottic airways (SALSA) vs Intubate-Surfactant-Extubate (INSURE) in Preterm Neonates with Respiratory Distress Syndrome: A Randomized 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 |
DrSatish saluja |
Designation |
Co- Chairperson & Senior Consultant |
Affiliation |
Department of Neonatology, Sir Gangaram Hospital |
Address |
Department of Neonatology,1st floor, Room no: F-85
Sir Ganga Ram Hospital
Central DELHI 110060 India |
Phone |
|
Fax |
|
Email |
satishsaluja@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Srikanth kandi |
Designation |
DrNB resident |
Affiliation |
Sir Gangaram Hospital |
Address |
Dr.srikanth kandi,
GAB ID-3377, 1st floor NICU
Department of Neonatology,
Sir Gangaram Hospital
Central DELHI 110060 India |
Phone |
8247785484 |
Fax |
|
Email |
kandisrikanth@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Srikanth kandi |
Designation |
DrNB resident |
Affiliation |
Sir Gangaram Hospital |
Address |
Dr.srikanth kandi,
GAB ID-3377, 1st floor NICU
Department of Neonatology,
Sir Gangaram Hospital
DELHI 110060 India |
Phone |
8247785484 |
Fax |
|
Email |
kandisrikanth@yahoo.com |
|
Source of Monetary or Material Support
|
Sir Ganga Ram Hospital,
Rajinder Nagar,
New Delhi - 110060, INDIA |
|
Primary Sponsor
|
Name |
Srikanth kandi |
Address |
siteno-22, plot no-13,second floor , new rajinder nagar, newdelhi-110060 |
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 srikanth kandi |
Sir Gangaram Hospital |
Department of neonatology, 1st floor, NICU
Rajinder Nagar,
New Delhi - 110060, INDIA Central DELHI |
8247785484
kandisrikanth@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
EC-SGRH |
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 |
SALSA technique |
Use of laryngeal mask airway for surfactant administration (SALSA). the duration of procedure will take about 10-15 minutes |
Comparator Agent |
INSURE technique |
Use of Endotracheal tube for surfactant administration (InSurE) |
|
Inclusion Criteria
|
Age From |
0.00 Day(s) |
Age To |
28.00 Day(s) |
Gender |
Both |
Details |
Preterm neonates with respiratory distress syndrome on CPAP with requirement of FiO2 >0.3 and PEEP of 6cm H2O or more |
|
ExclusionCriteria |
Details |
Neonates intubated before enrolment
Major congenital malformations
Refusal to participate
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Success of surfactant delivery: attainment of following parameters within 60 minutes of delivery of Surfactant:
1. FiO2 0.3
2. No / mild retractions
3. RR: 80 bpm
|
60 minutes after surfactant delivery
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Need for invasive ventilation during 72 hrs following surfactant delivery
Number of doses of surfactant required
Time taken to perform the procedure
Cumulative duration of respiratory support (non-invasive & invasive ventilation) during hospital stay
Cumulative duration of following events during & within 10 minutes of the procedure
a. Apnoea
b. Preductal oxygen saturations below 85%
c. Heart rate: bradycardia defined as HR 100 bpm
Neonatal pain assessment with each procedure: This will be assessed by N-PASS scale
Proceduralist stress score with each procedure by using Likert scale
Incidence of IVH, Pneumothorax and BPD
Amount of gastric leakage of surfactant
|
Immediately after surfactant delivery & at discharge of the baby |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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
|
Phase 4 |
Date of First Enrollment (India)
|
10/07/2023 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
None Yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Surfactant
replacement therapy is one of the most common procedures performed in the neonatal
intensive care unit for preterm neonates. Intubate,
Surfactant, Extubate is the most commonly used technique,
which involves intubation and may result in ventilator associated lung injury. Surfactant administration through laryngeal and
supraglottic airways is a newer modality in which a supraglottic airway device
is used to deliver surfactant, thus eliminating the need for intubation and its
adverse effects. We plan to conduct this randomized control trial with non-inferiority
study design. During the study, we anticipate enrolling at least 20 subjects in
each group, consisting of preterm neonates with respiratory distress syndrome who
receive surfactant through either of the two techniques. The primary outcome is
success of surfactant therapy which is defined by the attainment of the
following parameters within 60 minutes of administration of surfactant: FiO2
<0.3, no/minimal retractions and respiratory rate <80 bpm. The Surfactant administration through laryngeal and
supraglottic airways is anticipated to be non-inferior to conventional
technique, however with certain other benefits like ease of delivery, lesser
discomfort and instability of the neonate. The secondary outcome measures will
be need for invasive ventilation within 72 hours of surfactant delivery, number
of doses of surfactant required, total time taken to perform the procedure,
gastric leakage of surfactant, cumulative duration of respiratory support (both
invasive and non-invasive) during hospital stay, total duration of the
following events during and within 10 minutes after delivery of surfactant - apnea,
preductal oxygen saturation <85% and heart rate less than 100 bpm, incidence
of pneumothorax, bronchopulmonary dysplasia and intraventricular hemorrhage,
Neonatal pain assessment will be done using Neonatal-Pain Agitation and Sedation
Scale and proceduralist stress score
will be assessed by Likert scale. |