440
Participants
Start Date
September 25, 2025
Primary Completion Date
December 31, 2028
Study Completion Date
March 30, 2029
Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA)
While the infant is spontaneously breathing on nasal CPAP, the NICU physician will place the supraglottic airway device (SAD) and assess airway adequacy via CO₂ detection, chest movement, bilateral breath sounds, gastric insufflation, oxygen saturation, and heart rate. Each placement attempt should last no more than 30 seconds, with up to two attempts allowed. Surfactant (Curosurf 200 mg/kg) will be given slowly in 1-2 ml aliquots via a CE-marked preterm-sized SAD, Neo i-gel® (sizes 0.85, 0.75, 0.65; Intersurgical Ltd). The infant should primarily breathe spontaneously with PEEP from a T-piece resuscitator and receive gentle PPV if needed. PPV is continued for 30 seconds after surfactant administration before SAD removal. A reservoir bag may be used secondarily to provide PPV. If surfactant delivery via SALSA fails, the INSURE method (Intubation-Surfactant-Extubation) will be attempted.
Intubation - Surfactant administration - Extubation (INSURE)
Study participants will receive surfactant therapy administered via brief endotracheal intubation - surfactant administration - and extubation (INSURE). Infants will be ventilated using a T-piece resuscitator with PEEP of 6 cm H20 and positive pressure ventilation (20 cm H20) for a couple of minutes (no more than 15 minutes) with adjustable FiO2. No mechanical ventilation will be used. Secondarily a reservoir-bag will be used for ventilation.
RECRUITING
Phu San Hanoi Hospital - Hanoi Obstetrics and Gynecology Hospital, Hanoi
Göteborg University
OTHER
University of Padova
OTHER
Hanoi Obstetrics and Gynecology Hospital
OTHER
Karolinska Institutet
OTHER