Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants
NCT ID: NCT06786039
Last Updated: 2025-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2025-01-20
2030-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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NIV-NAVA application
Preterm infants born between 27 weeks 0 days to 31 weeks 6 days of gestation requiring respiratory support within 48 hours after birth
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Preterm infants who require respiratory support within the first 48 hours of life
Exclusion Criteria
* Preterm infants who do not require any respiratory support within the first 48 hours of life.
* Preterm infants with congenital anomalies affecting the lungs, heart, or other organs that could influence breathing
* Infants whose parents do not consent to participate in the study
1 Hour
48 Hours
ALL
No
Sponsors
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Korea University Anam Hospital
OTHER
Responsible Party
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Juyoung Lee
Professor
Locations
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Seoul National Bundang Hospital NICU
Seongnam-si, Gyeonggi-do, South Korea
Korea University Anam Hospital, NICU
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024AN0554
Identifier Type: -
Identifier Source: org_study_id
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