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

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.