Actively Recruiting
Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants
Led by Korea University Anam Hospital · Updated on 2025-06-17
80
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of Non-invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA) on both short-term clinical outcomes and long-term neurodevelopment in very preterm infants. This observational study focuses on infants born between 27 weeks 0 days and 31 weeks 6 days of gestation who need respiratory support shortly after birth. The goal is to understand how NIV-NAVA impacts their health and development during their stay in neonatal intensive care and beyond. The study involves initiating respiratory support using NIV-NAVA within 48 hours after birth. The respiratory settings are tailored to each infant's condition, with options to switch to nasal continuous airway pressure or high flow nasal cannula as needed. For infants with respiratory distress syndrome, lung surfactant is given using a less invasive method to avoid intubation when possible. If intubation is necessary, early extubation to NIV-NAVA is encouraged, but invasive ventilation may be used if the infant's condition worsens. Participants will be closely monitored throughout their hospital stay, which can last up to three months in the neonatal intensive care unit. Researchers will track the rate of NIV-NAVA failure and various respiratory and neurological outcomes, including bronchopulmonary dysplasia, brain hemorrhages, and lung complications. They will also perform brain MRI scans and follow neurodevelopmental progress using standardized developmental assessments up to three years of age.
CONDITIONS
Brief Title
Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 3 months during hospital stay in neonatal intensive care unit
Participants are observed while receiving various types of respiratory support based on their clinical conditions, including non-invasive neurally adjusted ventilatory assist (NIV-NAVA) and other respiratory support methods as needed.
Continuous monitoring during hospital stay
Duration - From 37 weeks postmenstrual age up to 39 months of age
Participants undergo developmental assessments and brain imaging to monitor long-term outcomes after initial hospital care.
Several follow-up visits at term equivalent age and at 18-39 months of corrected age
Trial Site Locations
Total: 2 locations
1
Seoul National Bundang Hospital NICU
Seongnam-si, Gyeonggi-do, South Korea, 13620
Not Yet Recruiting
2
Korea University Anam Hospital, NICU
Seoul, South Korea, 02841
Actively Recruiting
Research Team
J
Juyoung Lee, Professor
H
Hannah Cho, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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