Comparison of NIV-NAVA vs. N-CPAP After Extubation in Preterm Infants Study

Infant, Premature Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590757
• Other study ID #: 2015-1917
• Status: Completed
• Phase: N/A
• Start date: December 10, 2015
• Est. completion date: January 23, 2021

Study information

• Verified date: December 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 23, 2021
• Est. primary completion date: November 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Endotracheal Extubation
• Infant, Premature

Intervention

Device:
• NIV-NAVA
Non-invasive neurally adjusted ventilatory assist
• N-CPAP
Nasal-continuous positive airway pressure

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Children's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extubation failure	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	extubation - 72 hours
Secondary	FiO2 >0.6 to maintain SpO2 = 88% after extubation	Participants will be followed for the extubation failure within 3 days after extubation	extubation - 72 hours
Secondary	Severe apnea event requiring bag and mask resuscitation	Participants will be followed for the extubation failure within 3 days after extubation	extubation - 72 hours
Secondary	FiO2 >0.6 to maintain SpO2 = 88% after extubation	Participants will be followed for the extubation failure within 7 days after extubation	extubation - 7 days
Secondary	pH < 7.2 with pCO2 > 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings	Participants will be followed for the extubation failure within 7 days after extubation	extubation - 7 days
Secondary	Severe apnea event requiring bag and mask resuscitation	Participants will be followed for the extubation failure within 7 days after extubation	extubation - 7 days
Secondary	Bronchopulmonary dysplasia	Participants will be followed for the duration of hospital stay	postmenstrual age 36 weeks
Secondary	Duration of noninvasive ventilation	Participants will be followed for the duration of hospital stay	postmenstrual age 40 weeks (until discharge)
Secondary	Duration of inspired oxygen supply	Participants will be followed for the duration of hospital stay	postmenstrual age 40 weeks (until discharge)
Secondary	Duration of hospital stay	Participants will be followed for the duration of hospital stay	postmenstrual age 40 weeks (until discharge)
Secondary	Adverse events	Participants will be followed for 3 days after extubation	extubation - 3days