Endotracheal Extubation, Infant, Premature
Conditions
Keywords
non-invasive ventilation, non-invasive neurally adjusted ventilatory assist, nasal continuous positive airway pressure
Brief summary
This study is a randomized controlled study to compare if a a non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is better than nasal continuous positive airway pressure (N-CPAP) after extubation in infants' \< 30 weeks of gestation.
Interventions
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Days to 6 Weeks
Healthy volunteers
No
Inclusion criteria
* postconceptional age less than 30+0 weeks * infants who fulfill the the criteria for extubation for 6 hours extubation criteria: Ventilator rate ≤ 25 breaths/min, Peak inspiratory pressure (PIP) ≤ 16cmH2O, Fractional inspired oxygen (FiO2) ≤ 0.3
Exclusion criteria
* conditions which will decrease life expectancy * major anomalies which will decrease life expectancy * any anomalous conditions which involve upper and lower airway * neuromuscular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extubation failure | extubation - 72 hours | Failure criteria * pH \< 7.2 with pCO2 \> 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings * Severe apnea event requiring bag and mask resuscitation * FiO2 \>0.6 to maintain SpO2 ≥ 88% after extubation * Frequent desaturations (\< 85%) ≥ 3/hr not responding to increased ventilatory settings or an increase in Fio2 to 1.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe apnea event requiring bag and mask resuscitation | extubation - 72 hours | Participants will be followed for the extubation failure within 3 days after extubation |
| pH < 7.2 with pCO2 > 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings | extubation - 7 days | Participants will be followed for the extubation failure within 7 days after extubation |
| Bronchopulmonary dysplasia | postmenstrual age 36 weeks | Participants will be followed for the duration of hospital stay |
| FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation | extubation - 72 hours | Participants will be followed for the extubation failure within 3 days after extubation |
| Duration of inspired oxygen supply | postmenstrual age 40 weeks (until discharge) | Participants will be followed for the duration of hospital stay |
| Duration of hospital stay | postmenstrual age 40 weeks (until discharge) | Participants will be followed for the duration of hospital stay |
| Adverse events | extubation - 3days | Participants will be followed for 3 days after extubation |
| Duration of noninvasive ventilation | postmenstrual age 40 weeks (until discharge) | Participants will be followed for the duration of hospital stay |
Countries
South Korea
Outcome results
None listed