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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive NAVA | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of bronchopulmonary dysplasia (BPD) | diagnosed according to the Jensen Criteria | at 36 weeks of postmenstrual age |
| Duration of non-invasive ventilation | each of NIV-NAVA, nasal continuous positive airway pressure, high flow nasal cannula |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to the NICU in Korea University Anam Hospital will be recruited over a 2-year period.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juyoung Lee, Professor | Contact | +82-2-920-5647 | juyounglee@korea.ac.kr | |
| Hannah Cho, Professor | Contact | hannahv2@korea.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National Bundang Hospital NICU | Not yet recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42252137 | Derived | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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 | 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 | 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 | 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) | 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 | 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) | 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) | 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 | 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 | 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 | 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). | 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 | 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 | 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). | 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. | 33-39 months of age |
| Korea University Anam Hospital, NICU | Recruiting | Seoul | 02841 | South Korea |
|
| D000091642 | Urogenital Diseases |