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.
Study Type
OBSERVATIONAL
Enrollment
80
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.
Seoul National Bundang Hospital NICU
Seongnam-si, Gyeonggi-do, South Korea
NOT_YET_RECRUITINGKorea University Anam Hospital, NICU
Seoul, South Korea
RECRUITINGRate 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)
Time frame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Rate of bronchopulmonary dysplasia (BPD)
diagnosed according to the Jensen Criteria
Time frame: at 36 weeks of postmenstrual age
Duration of non-invasive ventilation
each of NIV-NAVA, nasal continuous positive airway pressure, high flow nasal cannula
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
Incidence of patent ductus arteriosus (PDA)
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defined by clinical and/or echocardiographic criteria requiring symptomatic treatment (except prophylaxis)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 33-39 months of age