RecruitingNCT06786039

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


Sponsor

Korea University Anam Hospital

Enrollment

80 participants

Start Date

Jan 20, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 1 HourMax Age: 48 Hours

Inclusion Criteria2

  • Preterm infants born between 27 weeks 0 days to 31 weeks 6 days of gestation
  • Preterm infants who require respiratory support within the first 48 hours of life

Exclusion Criteria4

  • Preterm infants who die within the first 48 hours of life
  • 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

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Interventions

PROCEDURENon-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.


Locations(2)

Seoul National Bundang Hospital NICU

Seongnam-si, Gyeonggi-do, South Korea

Korea University Anam Hospital, NICU

Seoul, South Korea

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NCT06786039


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