← Back to all trials
Recruiting
NCT05711966
COMPARISON OF INRECSURE AND LISA IN PRETERM NEONATES WITH RDS: A RANDOMIZED CONTROLLED TRIAL
Conditions: Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
Sex: All
Ages: 24 Weeks – 27 Weeks
Phase: NA
Enrollment: 381
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Location: Italy
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).
Eligibility Criteria
Inclusion Criteria:Infants satisfying the following inclusion criteria will be eligible to participate:Born at 24+0-27+6 in a tertiary neonatal intensive care unit participating in the trial (and)Breathing independently and sufficiently with only nasal CPAP or NIPPV for respiratory support (and)Written parental consent has been obtained (and)Failing nasal CPAP or NIPPV during the first 24 hours of lifeExclusion Criteria:Severe birth asphyxia or a 5-minute Apgar score less than 3Prior endotracheal intubation for resuscitation or insufficient respiratory driveProlonged (>21 days) premature rupture of membranesPresence of major congenital abnormalitiesHydrops fetalisInherited disorders of metabolism
Source: ClinicalTrials.gov (NCT05711966). StuddyBuddy aggregates publicly available trial information.