| 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 |
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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
|
|
|
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 |
|
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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 |
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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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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. |