Comparing Heated Humidified High-flow Nasal Cannula Therapy and Nasal Continuous Positive Airway Pressure (nCPAP) Ventilation Methods for the Prevention of Extubation Failure in Preterm Infants Less Than 32 Weeks' Gestational Age: Randomized Clinical Trial
Sponsor study identifier
interventional
200
0 countries
N/A
Study Start
August 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Purpose is to show that HHHFNC method is as effective and safe as nCPAPand even more comfortable than it as non-invasive respiratory support for the prevention of extubation failure in preterm with gestational age of 26-32 weeks. Patients requiring mechanical ventilation for at least 6 hours on the first 7 postnatal days will be included in the study.When patients were Fi O2 \< 0,40, Pa CO2 \< 65 mmHg, pH\> 7.20, MAP (mean airway pressure) \<7 cm H2O, they will be extubated if statistically stable.Oxygen-air mixture of 4-6 l / min flow rate will be set in HHHFNC group, and pressure will be set to 5-8 cm H2O in NCPAP group. When flow is 2 l / min, FiO2 is\<0.30 at 24 hours and above, free oxygen will be introduced. In NCPAP group, when pressure is 5 cm H2O and FiO2 \< 0.30 at 24 hours and above, free oxygen will be introduced.
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September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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August 2016
Date type not reportedThis date has not been verified as actual or estimated.
August 15, 2016
Actual (reported)September 2, 2016
Actual (reported)July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
extubation failure
The effectiveness of HHHFNC and nCPAP techniques for the prevention of extubation failure within 7 days following the first extubation in preterms in need of mechanical ventilation within the first 7 postnatal days
7 day
Heated humidified high-flow nasal cannula therapy device for post extubation
Nasal continuous positive airway pressure for post extubation
Patients requiring mechanical ventilation for at least 6 hours on the first 7 postnatal days will be included in the study.When patients were Fi O2 \< 0,40, Pa CO2 \< 65 mmHg, pH\> 7.20, MAP (mean airway pressure) \<7 cm H2O, they will be extubated if statistically stable.Oxygen-air mixture of 4-6 l / min flow rate will be set in HHHFNC group, and pressure will be set to 5-8 cm H2O in NCPAP group. When flow is 2 l / min, FiO2 is\<0.30 at 24 hours and above, free oxygen will be introduced. In NCPAP group, when pressure is 5 cm H2O and FiO2 \< 0.30 at 24 hours and above, free oxygen will be introduced.
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First Submitted
August 15, 2016
First Posted
September 2, 2016
Study Start
August 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 13, 2016
Record last verified: 2016-08
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