Impact of a non-invasive ventilation method on very preterm infants
Official title: Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants
Run by Korea University Anam Hospital · NCT06786039 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 1 Hour to 48 Hours |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Korea University Anam Hospital Academic / other |
| Locations | 2 sites (Seongnam-si, Gyeonggi-do and 1 other locations) |
| Status | Recruiting |
| Started | January 20, 2025 |
| Main results expected | December 20, 2029 |
| Study ends | December 20, 2030 |
| Registry record updated | August 5, 2026 |
| Trial ID | NCT06786039 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is being explored in this specific context, similar non-invasive ventilation methods have shown promise in other studies involving preterm infants.
Who can join: the full rules
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 it's running
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Korea University Anam Hospital, NICU
Seoul, Seoul, South Korea Recruiting -
Seoul National Bundang Hospital NICU
Seongnam-si, Gyeonggi-do, South Korea Not yet recruiting
Study contacts
- Study coordinator: Juyoung Lee, Professor
- Email: juyounglee@korea.ac.kr
- Phone: +82-2-920-5647
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Detection of Respiratory Events in Extremely Preterm Infants Using Acoustic Monitoring
A new acoustic monitoring approach is being tested to detect breathing problems in very preterm babies to help NICU teams spot and manage apnea and related events.
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Early Nutrition Support for Extremely Preterm Infants
This initiative tests a nutrition bundle—personalized breast milk feeding, early zinc supplementation, and routine carnitine supplementation—for very preterm babies to see if it improves growth and development.
-
Using bubble CPAP sounds to measure airway pressure in premature infants
This project will try to see if the sounds made by bubble CPAP can tell us how much airway pressure very premature infants (born before 32 weeks) are actually receiving.
-
Early lung development in preterm babies with and without fetal growth restriction
This study will test whether ultrasound measurements of fetal lung volume, diaphragm thickness and heart function before 32 weeks can help predict breathing problems and later lung function in preterm babies with or without fetal growth restriction.
-
Positive feeding for preterm babies
This study will try a cue-based, parent-led feeding approach for preterm infants in the NICU to see if it can be put into practice and is acceptable to parents and staff.
-
Comparing air temperature control and skin control for preterm infants in incubators
This study is testing whether keeping preterm babies warm with air temperature control or skin control in incubators helps them grow better and stay healthier during their first ten days of life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.