Clinical trial NCT02590757: Comparison of NIV-NAVA vs. N-CPAP After Extubation in Preterm Infants Study
Official title: Comparison of Non-invasive Ventilation Neurally Adjusted Ventilatory Assist vs. Nasal Continuous Positive Airway Pressure After Extubation in Infants' < 30 Weeks of Gestation: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Extubation
Infant, Premature
Keywords: non-invasive ventilation
non-invasive neurally adjusted ventilatory assist
nasal continuous positive airway pressure
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 78
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Extubation failure
timeFrame: extubation - 72 hours
Secondary outcomes:
measure: FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation
timeFrame: extubation - 72 hours
measure: Severe apnea event requiring bag and mask resuscitation
timeFrame: extubation - 72 hours
measure: FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation
timeFrame: extubation - 7 days
measure: pH < 7.2 with pCO2 > 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings
timeFrame: extubation - 7 days
measure: Severe apnea event requiring bag and mask resuscitation
timeFrame: extubation - 7 days
measure: Bronchopulmonary dysplasia
timeFrame: postmenstrual age 36 weeks
measure: Duration of noninvasive ventilation
timeFrame: postmenstrual age 40 weeks (until discharge)
measure: Duration of inspired oxygen supply
timeFrame: postmenstrual age 40 weeks (until discharge)
measure: Duration of hospital stay
timeFrame: postmenstrual age 40 weeks (until discharge)
measure: Adverse events
timeFrame: extubation - 3days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Han-Suk Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shin SH, Shin SH, Kim SH, Song IG, Jung YH, Kim EK, Kim HS. Noninvasive Neurally Adjusted Ventilation in Postextubation Stabilization of Preterm Infants: A Randomized Controlled Study. J Pediatr. 2022 Aug;247:53-59.e1. doi: 10.1016/j.jpeds.2022.04.025. Epub 2022 Apr 20.