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

Not Applicable

Completed

• Conditions: Infant, Premature; Endotracheal Extubation
• Interventions: Device: NIV-NAVA; Device: N-CPAP

• Registration Number: NCT02590757
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-25
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-29
• Study Start: 2015-12-10
• Primary Completion: 2020-11-13
• Study Completion: 2021-01-23
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-05
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIV-NAVA	NIV-NAVA	Noninvasive ventilation in this group is practiced with NIV-NAVA
N-CPAP	N-CPAP	Patients in this group will receive nasal continuous positive airway pressure as routinely in neonatal intensive care unit.

Primary Outcome Measures

Name	Time	Method
Extubation failure	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 Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of