Prematurity Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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