RecruitingNot Applicable

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

South Korea80 participantsStarted 2025-01-20

Plain-language 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.

Who can participate

Age range

1 Hour – 48 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) failure

Timeframe: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months

Trial details

NCT IDNCT06786039

SponsorKorea University Anam Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-12-20

Contact for this trial

Juyoung Lee, Professor

+82-2-920-5647 juyounglee@korea.ac.kr

View on ClinicalTrials.gov More Preterm Infant trials

Who can participate

Age range

1 Hour – 48 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.