Preterm InfantNCT06786039
Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants
An observational study of Preterm Infant, run by Korea University Anam Hospital at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 48 hours
- Conditions the study is for
- Preterm Infant
- What is being tested?
- Non-invasive NAVA
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 20 Jan 2025to 20 Dec 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 48 hours
- All sexes
- No healthy volunteers
- Child
Study population: Patients admitted to the NICU in Korea University Anam Hospital will be recruited over a 2-year period.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hannah Cho, Professor contact
South Korea2 sites, 2 recruiting
- Not yet recruiting
Seoul National Bundang Hospital NICU
Seongnam-si, Gyeonggi-do, 13620
Young Hwa Jung, Professor, +31-787-3541, jyhtlcn@gmail.com
- Recruiting
Korea University Anam Hospital, NICU
Seoul, Seoul, 02841
Juyoung Lee, MD, PhD, +82-2-920-5647, juyounglee@korea.ac.kr
Juyoung Lee, MD, PhD
About this study
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.
- Conditions
- Preterm Infant
- Being tested
- Non-invasive NAVA
- Keywords
- infant, premature, Noninvasive NAVA
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive NAVAProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| NIV-NAVA application | Preterm infants born between 27 weeks 0 days to 31 weeks 6 days of gestation requiring respiratory support within 48 hours after birth Receives: Procedure: Non-invasive NAVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) failure
NIV-NAVA failure was defined as a participant requiring endotracheal intubation (except brief intubation for only surfactant administration)
Measured: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Secondary outcomes (17)
Rate of bronchopulmonary dysplasia (BPD)
diagnosed according to the Jensen Criteria
Measured: at 36 weeks of postmenstrual age
Duration of non-invasive ventilation
each of NIV-NAVA, nasal continuous positive airway pressure, high flow nasal cannula
Measured: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Incidence of periventricular leukomalacia (PVL)
diagnosed by brain ultrasound or MRI
Measured: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Duration of invasive ventilation
each of high-frequent oscillatory ventilation, conventional mechanical ventilation, NAVA etc
Measured: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Incidence of air leaks
including pneumothorax, pneumomediastinum and pulmonary interstitial emphysema
Measured: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Incidence of patent ductus arteriosus (PDA)
defined by clinical and/or echocardiographic criteria requiring symptomatic treatment (except prophylaxis)
Measured: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Time to achieve full enteral feeding
day of life when milk amount reaches 100 mL/kg/day or higher
Measured: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Incidence of intraventricular hemorrhage (IVH)
defined by the Papile criteria, using cranial ultrasonography (≥grade 2)
Measured: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Incidence of retinopathy of prematurity (ROP)
defined according to the international classification of ROP (≥stage 2)
Measured: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Total brain volume (mL)
Total brain volume (TBV) will be measured from Brain MRI
Measured: term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI
Intracranial volume (mL)
Intracranial volume (ICV) will be measured from Brain MRI
Measured: term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI
Relative sizes of volumes of particular regions of interest
relative sizes of volumes of particular regions of interest (ROIs) will be measured from brain MRI
Measured: term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI
Bayley Scales of Infant Development III - 2 yr
scale scores for each development areas (cognitive, language, motor) score range : 0-200 above average (1-2 SD, score 116-130) average ( 1 to 1 SD, score 85-115) below average (1 to-2 SD, score 84-70) well below average (<-2 SD, scores < 70).
Measured: 18-24 months of corrected age
Modified Checklist for Autism in Toddlers (M-CHAT)
autism spectrum disorder screening test result total score 0-2: low risk total score 3-7: moderate risk total score 8-20: high risk
Measured: 18-24 months of corrected age
MacArthur-Bates Communication Development Inventory
language evaluation questionnaire result The criterion for identifying risk for delayed language development was an expressive vocabulary size <10th percentile
Measured: 18-24 months of corrected age
Bayley Scales of Infant Development III - 3 yr
scale scores for each development areas (cognitive, language, motor) score range : 0-200 above average (1-2 SD, score 116-130) average ( 1 to 1 SD, score 85-115) below average (1 to-2 SD, score 84-70) well below average (<-2 SD, scores < 70).
Measured: 33-39 months of age
Child Behavior Checklist (CBCL)
behavior screening questionnaire result t-score ≤ 59: non-clinical symptoms, t-score between 60 and 64: at risk for problem behaviors t-score ≥ 65: clinical symptoms.
Measured: 33-39 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start20 Jan 2025
- Primary completion20 Dec 2029 (estimated)
- Study completion20 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juyoung Lee, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786039
- Sponsor's protocol ID
- 2024AN0554
- Status last verified
- Aug 2026
- First submitted
- 6 Jan 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cho H, Jung YH, Park J, Yang HJ, Kim MJ, Lee J. Feasibility of NIV-NAVA as a primary respiratory support and its clinical impacts in a targeted group of preterm infants: protocol for a prospective observational study. BMJ Open. 2026 Jun 7;16(6):e114353. doi: 10.1136/bmjopen-2025-114353.
PubMed 42252137