NCT06786039

Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Korea University Anam Hospital · Academic / Other
• Sex: All
• Age: 1 Hour – 48 Hours
• Healthy volunteers: Not accepted

Summary

This is a prospective observational study investigating the impact of NIV-NAVA on short-term clinical outcomes and long-term neurodevelopment in very preterm infants.

Conditions

• Preterm Infant

Interventions

Type	Name	Description
PROCEDURE	Non-invasive NAVA	Initiate respiratory assist with NIV-NAVA within 48 hours. The setting of respiratory support will be adjusted based on clinical conditions of each subject. NIV-NAVA could be switched to nasal continuous airway pressure or high flow nasal cannula, and it also could be stopped after initial stabilization. In cases of respiratory distress syndrome, lung surfactant will be administered via the less invasive surfactant administration (LISA) method and avoid endotracheal intubation whenever possible. For who intubated in the delivery room, extubation with NIV-NAVA should be considered as soon as possible. Endotracheal intubation with invasive ventilation could be applied when clinical deteriorations happens.

Timeline

• Start date: 2025-01-20
• Primary completion: 2029-12-20
• Completion: 2030-12-20
• First posted: 2025-01-22
• Last updated: 2025-06-17

Locations

2 sites across 1 country: South Korea