Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates With Respiratory Distress Syndrome

NACompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

September 20, 2024

Primary Completion Date

July 13, 2025

Study Completion Date

August 1, 2025

Conditions
Respiratory Distress Syndrome, Newborn
Interventions
DEVICE

Surfactant Administration Through Laryngeal or Supraglottic Airways

While the child is spontaneously breathing on nasal CPAP treatment, the neonatal intensive care (NICU) physician will place the LMA and assess for adequate airway by CO2-detection, chest movement, pulmonary auscultation of bilateral breath sounds, gastric insufflation, oxygen saturation and heart rate. A placement attempt should not last more than 30 seconds. Surfactant will be administered slowly in 1-2 ml aliquots (Curosurf 200 mg/kg) via an appropriate size laryngeal mask airway. The neonate should primarily be spontaneously breathing and if needed receives gentle supportive positive pressure ventilation (PPV). Gentle supportive PPV is given for 30 seconds after surfactant is administered, before LMA is removed.

Trial Locations (1)

118000

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

All Listed Sponsors
collaborator

Hanoi Medical University

OTHER

collaborator

Hanoi Obstetrics and Gynecology Hospital

OTHER

collaborator

Göteborg University

OTHER

lead

Karolinska Institutet

OTHER

NCT06606444 - Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates With Respiratory Distress Syndrome | Biotech Hunter | Biotech Hunter