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

Seoul National University Hospital78 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Endotracheal Extubation Infant, Premature

Interventions

NIV-NAVADEVICE

Non-invasive neurally adjusted ventilatory assist

N-CPAPDEVICE

Nasal-continuous positive airway pressure

Eligibility

Sex: ALLMin age: 2 DaysMax age: 6 Weeks

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Children's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: extubation - 72 hours

Secondary Outcomes

FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation

Participants will be followed for the extubation failure within 3 days after extubation

Time frame: extubation - 72 hours

Severe apnea event requiring bag and mask resuscitation

Participants will be followed for the extubation failure within 3 days after extubation

Time frame: extubation - 72 hours

FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation

Participants will be followed for the extubation failure within 7 days after extubation

Time frame: extubation - 7 days

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

Time frame: extubation - 7 days

Severe apnea event requiring bag and mask resuscitation

Participants will be followed for the extubation failure within 7 days after extubation

Time frame: extubation - 7 days

Bronchopulmonary dysplasia

Participants will be followed for the duration of hospital stay

Data from ClinicalTrials.gov

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