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CTRI Number  CTRI/2025/12/098332 [Registered on: 02/12/2025] Trial Registered Prospectively
Last Modified On: 01/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   our study will try to determine the difference efficacy two different oxygen levels as starting point to administer a drug to reduce respiratory distress in premature babies who are already on non invasive respiratory support 
Scientific Title of Study   Comparison of efficacy between 35 percent versus 30 percent inspired oxygen fraction threshold with non invasive ventilation (NIPPV) as respiratory support for surfactant administration in respiratory distress syndrome among preterm infants by Less Invasive Surfactant Administration (LISA) technique 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  BIJAN SAHA 
Designation  PROFESSOR  
Affiliation  Institute of Post Graduate Medical Education and Research 
Address  Department of Neonatology, Division- Neonatal Intensive Care Unit, Room no.1, 244 AJC Bose Road, PS-Bhowanipore

Kolkata
WEST BENGAL
700020
India 
Phone  9051389120  
Fax    
Email  bijansaha18@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  BIJAN SAHA 
Designation  PROFESSOR  
Affiliation  Institute of Post Graduate Medical Education and Research 
Address  Department of Neonatology, Division- Neonatal Intensive Care Unit, Room no.1, 244 AJC Bose Road, PS-Bhowanipore

Kolkata
WEST BENGAL
700020
India 
Phone  9051389120  
Fax    
Email  bijansaha18@gmail.com  
 
Details of Contact Person
Public Query
 
Name  BIJAN SAHA 
Designation  PROFESSOR  
Affiliation  Institute of Post Graduate Medical Education and Research 
Address  Department of Neonatology, Division- Neonatal Intensive Care Unit, Room no.1, 244 AJC Bose Road, PS-Bhowanipore

Kolkata
WEST BENGAL
700020
India 
Phone  9051389120  
Fax    
Email  bijansaha18@gmail.com  
 
Source of Monetary or Material Support  
Institute of Postgraduate Medical Education and Research, Kolkata 
 
Primary Sponsor  
Name  Institute of Post Graduate Medical Education and Research 
Address  244 AJC Bose Road, Bhowanipore, Kolkata- 700020 
Type of Sponsor  Government medical college 
 
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 Bijan Saha  Institute of Post Graduate Medical Education and Research  Department on Neonatology, Division- Neonatal Intensive Care Unit, Room no.1,244 AJC Bose Road, PS-Bhowanipore, Kolkata
Kolkata
WEST BENGAL 
9051389120

bijansaha18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGMER RESEARCH OVERSIGHT COMMITTEE   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 
Comparator Agent  30 percent as FiO2 threshold for surfactant administration   In this group, 30 percent FiO2 will be be taken as threshold for surfactant administration by LISA (less invasive surfactant administration) technique in preterm babies (intramural preterm babies with gestational age between 24-34 weeks) who develop respiratory distress syndrome after birth and are already on Non Invasive respiratory support (NIPPV)  
Intervention  35 percent as FiO2 threshold for surfactant administration   In this group, 35 percent FiO2 will be be taken as threshold for surfactant administration by LISA (less invasive surfactant administration) technique in preterm babies (intramural preterm babies with gestational age between 24-34 weeks) who develop respiratory distress syndrome after birth and are already on Non Invasive respiratory support (NIPPV)  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Day(s)
Gender  Both 
Details  intramural Preterm babies with gestational age between 24 to 34 weeks diagnosed with RDS and eligible for surfactant administration by the LISA technique will be enrolled in this study
RDS will be diagnosed clinically initially and later confirmed by chest X-ray. 
 
ExclusionCriteria 
Details  Baby with major congenital anomaly ,
Perinatal asphyxia (Cord blood pH less than 7.0, APGAR score less than 3 for more than 5 minutes, signs of neurological dysfunction and evidence of multiple organ dysfunction), Intubated at the delivery room,
An alternative cause of respiratory distress,
Any baby requiring mechanical ventilation and surfactant administration 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Requirement of intubation   Within day 3 of life 
 
Secondary Outcome  
Outcome  TimePoints 
Complications occurring during the procedure (Surfactant reflux during the procedure, SpO2 less than 85 percent, hypotension with mean below GA, bradycardia less than 80 bpm, nasal haemorrhage),
Need for the second dose of Surfactant,
Duration of respiratory support (invasive and non-invasive),
Pulmonary hemorrhage,
Pulmonary air leak syndromes,
Hemodynamically significant PDA requiring treatment,
Grade 3 and grade 4 IVH,
Periventricular Leukomalacia(PVL),
ROP requiring Laser treatment,
NEC stage 2 and above,
Duration of hospital stay,
Bronchopulmonary dysplasia (BPD)
Death before hospital discharge 
throughout the hospital stay 
 
Target Sample Size   Total Sample Size="256"
Sample Size from India="256" 
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 2/ Phase 3 
Date of First Enrollment (India)   12/12/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The development of respiratory distress syndrome (RDS) involves multiple factors, with surfactant deficiency remaining the primary contributor. In the absence of a clinically practical method to promptly and accurately assess surfactant levels in the lungs of preterm infants, other indicators have been utilised to determine RDS severity. Among these, the requirement for a fraction of inspired oxygen is the most widely applied. The recommended approach for managing preterm infants involves stabilisation using NCPAP, with early surfactant administration if intubation becomes necessary. However, the specific fraction of inspired oxygen level at which surfactant should be given remains uncertain. Although extensive research has focused on optimising surfactant use, there is limited evidence defining the ideal fraction of inspired oxygen threshold, resulting in practice variability and dependence on low-quality data. The reliability of fraction of inspired oxygen alone as an indicator of RDS severity and the need for surfactant has been questioned since it can be affected by various factors, including initial respiratory support with CPAP or NIPPV (Non Invasive Intermittent Positive Pressure Ventilation). Guidelines on the fraction of inspired oxygen threshold for surfactant replacement recommend only CPAP pressure, not mean airway pressure (MAP). There is also a paucity of data on fraction of inspired oxygen threshold studies on NIPPV.  With NIPPV respiratory support, providing better lung recruitment, consistent and higher mean airway pressure (MAP), the fraction of inspired oxygen threshold should be higher than CPAP respiratory support. We hypothesize that 35 percent fraction of inspired oxygen is as good as 30 percent fraction of inspired oxygen as a threshold for surfactant administration with NIPPV respiratory support by the LISA technique in infants with respiratory distress syndrome.

Methodology- Intramural Preterm babies with gestational age between 24 to 34 weeks diagnosed with RDS and eligible for surfactant administration by the LISA technique will be enrolled in this study. All eligible infants with RDS requiring either fraction of inspired oxygen more than equal to 35 percent or fraction of inspired oxygen more than 30 percent on Non-invasive positive pressure ventilation to maintain saturation 90 to 95 percent in the first 6 hours of life will be randomised to receive surfactant by LISA technique by Poractant alpha (Curosurf). The primary endpoint will be the requirement for intubation within 72 hours of life.

 

 



 
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