Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam

NARecruitingINTERVENTIONAL
Enrollment

440

Participants

Timeline

Start Date

September 25, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

March 30, 2029

Conditions
Respiratory Distress Syndrome in Premature Infant
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (1)

118000

RECRUITING

Phu San Hanoi Hospital - Hanoi Obstetrics and Gynecology Hospital, Hanoi

All Listed Sponsors
collaborator

Göteborg University

OTHER

collaborator

University of Padova

OTHER

collaborator

Hanoi Obstetrics and Gynecology Hospital

OTHER

lead

Karolinska Institutet

OTHER