Preterm Infant
Conditions
Keywords
infant, premature, Noninvasive NAVA
Brief 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.
Interventions
PROCEDURENon-invasive NAVA
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.
Sponsors
Korea University Anam Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 48 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) failure | through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months | NIV-NAVA failure was defined as a participant requiring endotracheal intubation (except brief intubation for only surfactant administration) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of bronchopulmonary dysplasia (BPD) | at 36 weeks of postmenstrual age | diagnosed according to the Jensen Criteria |
| Duration of non-invasive ventilation | through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months | each of NIV-NAVA, nasal continuous positive airway pressure, high flow nasal cannula |
| Incidence of periventricular leukomalacia (PVL) | through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months | diagnosed by brain ultrasound or MRI |
| Duration of invasive ventilation | through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months | each of high-frequent oscillatory ventilation, conventional mechanical ventilation, NAVA etc |
| Incidence of air leaks | through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months | including pneumothorax, pneumomediastinum and pulmonary interstitial emphysema |
| Incidence of patent ductus arteriosus (PDA) | through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months | defined by clinical and/or echocardiographic criteria requiring symptomatic treatment (except prophylaxis) |
| Time to achieve full enteral feeding | through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months | day of life when milk amount reaches 100 mL/kg/day or higher |
| Incidence of intraventricular hemorrhage (IVH) | through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months | defined by the Papile criteria, using cranial ultrasonography (≥grade 2) |
| Incidence of retinopathy of prematurity (ROP) | through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months | defined according to the international classification of ROP (≥stage 2) |
| Total brain volume (mL) | term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI | Total brain volume (TBV) will be measured from Brain MRI |
| Intracranial volume (mL) | term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI | Intracranial volume (ICV) will be measured from Brain MRI |
| Relative sizes of volumes of particular regions of interest | term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI | relative sizes of volumes of particular regions of interest (ROIs) will be measured from brain MRI |
| Bayley Scales of Infant Development III - 2 yr | 18-24 months of corrected age | 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). |
| Modified Checklist for Autism in Toddlers (M-CHAT) | 18-24 months of corrected age | autism spectrum disorder screening test result total score 0-2: low risk total score 3-7: moderate risk total score 8-20: high risk |
| MacArthur-Bates Communication Development Inventory | 18-24 months of corrected age | language evaluation questionnaire result The criterion for identifying risk for delayed language development was an expressive vocabulary size \<10th percentile |
| Bayley Scales of Infant Development III - 3 yr | 33-39 months of age | 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). |
| Child Behavior Checklist (CBCL) | 33-39 months of age | 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. |
Countries
South Korea
Contacts
CONTACTJuyoung Lee, Professor
CONTACTHannah Cho, Professor
Outcome results
None listed