535 - Can preterm sized supraglottic airways deliver surfactant in infants weighing 750–1500 g? A feasibility study

Publication Number: 3516.535

Mårten Larsson, Sahlgrenska Academy, Gothenburg University, Göteborg, Vastra Gotaland, Sweden; Hien Thi Thu. Vu, Karolinska Institutet, Stockholm, Stockholms Lan, Sweden; Huong Lien. Nguyen, Ha Noi Obstetrics and Gynecology Hospital, Ha Noi, Ha Noi, Vietnam; Linh Thi. Nguyen, Ha Noi Obstetric and Gynecology, Ha Noi, Ha Noi, Vietnam; Huong Thu. Nguyen, Other, Hanoi, Ha Noi, Vietnam; Luong Nhan Tran, Hanoi Obstetrics and Gynecology Hospital, Ha Noi, Ha Noi, Vietnam; Hanh Nguyen, Hanoi OBGY, Hà Nội, Ha Noi, Vietnam; Thanh Phuong Thi Tran, Phu San Ha Noi Hospital, Ha Noi, Ha Noi, Vietnam; Toan K Nguyen, Hanoi Obstetrics and Gynecology Hospital, Hanoi, Ha Noi, Vietnam; Thomas Drevhammar, Karolinska Institutet, Östersund, Jamtlands Lan, Sweden; Susanna Myrnerts Höök, Sachs' Children and Youth Hospital, Stockholm, Sweden Department of Global Public Health, Karolinska Institutet,Stockholm, Sweden Sachs' Children and Youth Hospital, Stockholm, Sweden, Stockholm, Stockholms Lan, Sweden; Phuong Thi Thu Pham, Phu San Hanoi Hospital, Hanoi, Ha Noi, Vietnam; Tobias Alfvén, Karolinska Institutet, Stockholm, Stockholms Lan, Sweden; Nicolas J. Pejovic, Karorlinska Institutet, Stockholm, Stockholms Lan, Sweden

Background: Surfactant administration via laryngeal or supraglottic airway (SALSA) is a promising strategy for preterm infants with respiratory distress syndrome (RDS). Available studies suggest SALSA is at least as effective as INSURE or nasal CPAP in preventing mechanical ventilation and may be safer by obviating the need for laryngoscopy. The absence of preterm-sized supraglottic airway devices (SADs) limits use in infants < 1,500 g-the group at highest risk of RDS.

Objective: To evaluate the feasibility and safety of device placement and surfactant administration using a preterm-sized SAD in infants with RDS and birth weight of 750-1500 g, within a middle-income country context

Design/Methods: This investigator-initiated, single-arm feasibility study was conducted in the level III NICU at Phu San Hanoi Hospital (~40,000 births/year). The study received approval from Vietnamese and Swedish IRBs and was registered at clinicaltrials.gov (NCT06606444). Newborn infants weighing 750-1500 g were enrolled after parental consent. Surfactant was delivered via preterm-sized SADs (Neo i-Gel®, Intersurgical Ltd) and data was collected by real-time observation, video recording, and continuous pulse oximetry. The primary outcome was successful device placement within two attempts, documented in real time. Secondary outcomes included procedure duration and physiologic stability, assessed by video review and continuous pulse oximetry. Data were entered into REDCap and analyzed descriptively.

Results: From September 2024 to July 2025, 45 preterm infants were enrolled (see Figure 1). Median birth weight was 1,300 g (range 800-1,500 g), and eight weighed < 1,000 g (see Table 1). The primary outcome-successful SAD placement within two attempts-was achieved in 98% of cases, with first-attempt success in 84%. In 27% of procedures, the provider was a first-time SAD user (Table 2). Median placement time was 21 s and median total procedure time 5.4 min. FiO₂ decreased from 0.40 to 0.25 one hour post-procedure. Three infants (7%) required intubation during the procedure, and 20 (44%) received mechanical ventilation within 72 h. Two infants with severe RDS experienced prolonged desaturation requiring positive-pressure ventilation, and one transient bradycardia episode ( < 60 bpm for 15 s) occurred; no serious adverse events were observed.

Conclusion(s): Use of the Neo i-Gel® SAD for surfactant delivery in infants weighing 800-1500 g is feasible, well tolerated, and easy to use. Next, we are conducting a non-inferiority randomized controlled trial (NeoSurf) comparing SALSA with INSURE to evaluate effectiveness and safety (NCT07098910).

Flow chart of eligibility, intervention and follow-up
SALSA, Surfactant through a Laryngeal or Supraglottic Airway;

Table 1 Demography


Table 2 Outcomes