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

Seoul National University

Status: Completed

Conditions: Endotracheal Extubation; Infant, Premature

Treatments: Device: N-CPAP; Device: NIV-NAVA

Study type: Interventional

Funder types: Other

Identifiers

NCT02590757

2015-1917

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 2 days to 6 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

NIV-NAVA

Active Comparator group

Description:

Noninvasive ventilation in this group is practiced with NIV-NAVA

Treatment:

Device: NIV-NAVA

N-CPAP

Active Comparator group

Description:

Patients in this group will receive nasal continuous positive airway pressure as routinely in neonatal intensive care unit.

Treatment:

Device: N-CPAP