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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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