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

Seoul National University Hospital1 site in 1 country78 target enrollmentDecember 10, 2015

ConditionsEndotracheal Extubation Infant, Premature

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Endotracheal Extubation
Sponsor: Seoul National University Hospital
Enrollment: 78
Locations: 1
Primary Endpoint: Extubation failure
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 10, 2015

End Date

January 23, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Han-Suk Kim

Professor, Director of Neonatal Intensive Care Unit

Seoul National University Hospital

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

Outcomes

Primary Outcomes

Extubation failure

Time Frame: 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 Outcomes

FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation(extubation - 7 days)
Bronchopulmonary dysplasia(postmenstrual age 36 weeks)
Duration of hospital stay(postmenstrual age 40 weeks (until discharge))
Severe apnea event requiring bag and mask resuscitation(extubation - 7 days)
pH < 7.2 with pCO2 > 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings(extubation - 7 days)
Duration of noninvasive ventilation(postmenstrual age 40 weeks (until discharge))
Duration of inspired oxygen supply(postmenstrual age 40 weeks (until discharge))
Adverse events(extubation - 3days)