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Comparison of INRECSURE and LISA in Preterm Neonates With RDS
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Summary
The primary hypothesis of this study is that surfactant administration by INtubate-RECruit-SURfactant-Extubate (IN-REC-SUR-E), via a high frequency oscillatory ventilation recruitment maneuver increases survival without BPD at 36 weeks' gestational age in spontaneously breathing infants born at 24+0-27+6 weeks' gestation affected by Respiratory Distress Syndrome (RDS) and failing nasal CPAP or nasal intermittent positive pressure ventilation (NIPPV) during the first 24 hours of life compared to less invasive surfactant administration (LISA).
Official title: Comparison of "IN-REC-SUR-E" and LISA in Preterm Neonates With Respiratory Distress Syndrome: a Randomized Controlled Trial (IN-REC-LISA Trial)
Key Details
Gender
All
Age Range
24 Weeks - 27 Weeks
Study Type
INTERVENTIONAL
Enrollment
381
Start Date
2023-01-09
Completion Date
2026-04-15
Last Updated
2023-02-17
Healthy Volunteers
No
Interventions
Ventilator for High-frequency Oscillatory Ventilation (HFOV)
This device will be used to perform an HFOV recruitment maneuver before surfactant administration
Less invasive surfactant administration (LISA)
SurfCath™ tracheal instillation catheter, or a 4- 6 F end-hole catheter, according to local protocols will be used for surfactant administration
Locations (1)
Fondazione Policlinico Agostino Gemelli IRCCS
Roma, Italy