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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | September 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 7 Days |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Zekai Tahir Burak Women's Health Research and Education Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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