Comparing HHHFNC and nCPAP Ventilation Methods for the Prevention of Extubation Failure in Preterm Infants
Primary Purpose
Extubation Failure, Prematurity
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Heated Humidified High-Flow Nasal Cannula
Sponsored by
About this trial
This is an interventional prevention trial for Extubation Failure
Eligibility Criteria
Inclusion Criteria: Preterm infants with gestational age between 26 weeks 0 days and 31 weeks 6 days will be included.
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Exclusion Criteria: 1- Presence of major congenital anomaly, 2- Presence of neuromuscular disease, 3- Need of surgery within 7 days following the extubation 4- Consent not provided or refused
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Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group 1
group 2
Arm Description
Heated humidified high-flow nasal cannula therapy device for post extubation
Nasal continuous positive airway pressure for post extubation
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02887846
First Posted
August 15, 2016
Last Updated
September 10, 2016
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02887846
Brief Title
Comparing HHHFNC and nCPAP Ventilation Methods for the Prevention of Extubation Failure in Preterm Infants
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
Purpose is to show that HHHFNC method is as effective and safe as nCPAP and 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.
Method
Primary Outcome Measures:
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
Secondary Outcome Measures:
the total duration of invasive and non-invasive respiratory support and the duration of free oxygen demand of patients
Premature morbidities such as PDA, NEC, ROP, IVH, BPDand sepsis
The degree of nasal trauma score and the degree of nasal mucosal injury
FiO2 levels first before extubation and 6 hours after extubation
The causes of reintubation such as apnea, acidosis, and increased need of FiO2
The reintubation predisposing factors such as pneumothorax, atelectasis, PDA after extubation
The weight change in the first 7-day period after extubation
The two groups in terms of neurodevelopmental changes
Study design 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.
Reintubation criteria is set as;
FiO2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher,
Apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation,
Persistent acidosis; presence of pH < 7.20 and PCO2 > 65 mmHg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis,
Severe respiratory distress,
Pulmonary haemorrhage and cardiopulmonary arrest.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extubation Failure, Prematurity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Active Comparator
Arm Description
Heated humidified high-flow nasal cannula therapy device for post extubation
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
Nasal continuous positive airway pressure for post extubation
Intervention Type
Device
Intervention Name(s)
Heated Humidified High-Flow Nasal Cannula
Other Intervention Name(s)
HHHFNC
Intervention Description
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.
Primary Outcome Measure Information:
Title
extubation failure
Description
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
Time Frame
7 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preterm infants with gestational age between 26 weeks 0 days and 31 weeks 6 days will be included.
-
Exclusion Criteria: 1- Presence of major congenital anomaly, 2- Presence of neuromuscular disease, 3- Need of surgery within 7 days following the extubation 4- Consent not provided or refused
-
12. IPD Sharing Statement
Learn more about this trial
Comparing HHHFNC and nCPAP Ventilation Methods for the Prevention of Extubation Failure in Preterm Infants
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