Impact of a non-invasive ventilation method on very preterm infants
Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants
Korea University Anam Hospital · NCT06786039
This study is testing a new breathing support method for very preterm infants to see if it helps them do better in the short and long term.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 1 Hour to 48 Hours |
| Sex | All |
| Sponsor | Korea University Anam Hospital (other) |
| Locations | 2 sites (Seongnam-si, Gyeonggi-do and 1 other locations) |
| Trial ID | NCT06786039 on ClinicalTrials.gov |
What this trial studies
This observational study investigates 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. The study focuses on infants born between 27 and 31 weeks of gestation who did not require immediate endotracheal intubation after birth. By monitoring these infants, researchers aim to gather data on the effectiveness of this ventilation method in improving health outcomes. The study is conducted at the Korea University Anam Hospital NICU.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born between 27 weeks 0 days and 31 weeks 6 days of gestation who do not require immediate intubation.
Not a fit: Patients who may not benefit from this study include those born before 27 weeks of gestation or those requiring immediate endotracheal intubation due to severe respiratory distress.
Why it matters
Potential benefit: If successful, this study could lead to improved respiratory support strategies for very preterm infants, enhancing their clinical outcomes and neurodevelopment.
How similar studies have performed: While this approach is being explored in this specific context, similar non-invasive ventilation methods have shown promise in other studies involving preterm infants.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Seongnam-si, Gyeonggi-do and 1 other locations
- Seoul National Bundang Hospital NICU — Seongnam-si, Gyeonggi-do, South Korea (NOT_YET_RECRUITING)
- Korea University Anam Hospital, NICU — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: Juyoung Lee, Professor
- Email: juyounglee@korea.ac.kr
- Phone: +82-2-920-5647
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preterm Infant, infant, premature, Noninvasive NAVA