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Войти в исследования The Journal of pediatrics · 2026
Feasibility of Surfactant Delivery via Preterm Supraglottic Airways in Infants with Birth Weights of 800-1500 g.
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Larsson Mårten, Vu Hien, Nguyen Linh Thi, Nguyen Huong Lien, Nguyen Huong Thu, Tran Nhan Luong, Nguyen Hanh, Thi Pham Phuong Thu, Nguyen Toan K, Elfvin Anders, Drevhammar Thomas, Mai Hung Trong, Myrnerts Höök Susanna, Alfvén Tobias, Pejovic Nicolas J
Аннотация
OBJECTIVE: To assess feasibility and safety of airway management and surfactant administration using newly developed preterm-sized supraglottic airways (SAs) in infants with respiratory distress syndrome and birth weight 750 -1500 g.
STUDY DESIGN: This investigator-initiated, single-arm interventional feasibility study was conducted in a level III neonatal intensive care unit at Phu San Hanoi Hospital (35 000 annual births). Infants with birth weights 750-1500 g were enrolled after parental consent. Surfactant was administered via preterm-sized SAs. The primary outcome was successful placement within 2 attempts. Video recordings were used to assess procedure characteristics and physiologic stability by continuous pulse oximetry. Data were summarized descriptively and compared for infants with weights of <1000 vs 1000-1500 g.
RESULTS: Forty-five infants (median birth weight: 1300 g; range: 800-1500 g) were enrolled. SA placement was successful in 98% of cases, with 82% on the first attempt. For 27% of cases, this was the provider's first SA use. The median time to successful airway placement was 21 seconds, and the entire procedure lasted a median of 5.4 minutes. Surfactant was delivered by SA in 93% of cases and the median fraction of inspired oxygen decreased from 0.40 to 0.25 1 hour post-procedure (P < .001). Three desaturations (<60%) and one bradycardia (<60 beats per minute) occurred; no other procedure-related serious adverse events were reported. No differences in response or adverse events were found in infants with birth weight <1000g.
CONCLUSIONS: Use of preterm sized SAs for surfactant delivery in infants weighing 800-1500 g was feasible and well tolerated. Large randomized controlled trials are needed to compare its efficacy and safety with conventional administration of surfactant.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06606444.
STUDY DESIGN: This investigator-initiated, single-arm interventional feasibility study was conducted in a level III neonatal intensive care unit at Phu San Hanoi Hospital (35 000 annual births). Infants with birth weights 750-1500 g were enrolled after parental consent. Surfactant was administered via preterm-sized SAs. The primary outcome was successful placement within 2 attempts. Video recordings were used to assess procedure characteristics and physiologic stability by continuous pulse oximetry. Data were summarized descriptively and compared for infants with weights of <1000 vs 1000-1500 g.
RESULTS: Forty-five infants (median birth weight: 1300 g; range: 800-1500 g) were enrolled. SA placement was successful in 98% of cases, with 82% on the first attempt. For 27% of cases, this was the provider's first SA use. The median time to successful airway placement was 21 seconds, and the entire procedure lasted a median of 5.4 minutes. Surfactant was delivered by SA in 93% of cases and the median fraction of inspired oxygen decreased from 0.40 to 0.25 1 hour post-procedure (P < .001). Three desaturations (<60%) and one bradycardia (<60 beats per minute) occurred; no other procedure-related serious adverse events were reported. No differences in response or adverse events were found in infants with birth weight <1000g.
CONCLUSIONS: Use of preterm sized SAs for surfactant delivery in infants weighing 800-1500 g was feasible and well tolerated. Large randomized controlled trials are needed to compare its efficacy and safety with conventional administration of surfactant.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06606444.