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is to compare introduction of two different NCPAP methods in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.
Study Design NCPAP support was provided with continuous positive airway pressure, which was generated by a neonatal ventilator (SLE; Infant Flow System, Viasys Corp., USA) and infant flow-driver device (SLE; The respiratory parameter settings were a PEEP of 5-8 cmH2O. CPAP was stopped when PEEP 5 cmH2O and infants showed no signs of RDS with FiO2 <0.30.
Under non-invasive respiratory support, in case of FiO2 is ≥ 0.40, surfactant will be given as early rescue therapy by means of non-invasive method (by using a thin catheter - take care method- while spontaneous breathing continues) in order to keep target oxygen saturation between 90-95 %. The second dose of surfactant will be given 6 hours after the first dose by means on non-invasive method in order to keep target oxygen saturation between 90-95 % in case of FiO2 need is ≥ 0.30.
Non-invasive respiratory support failure is set as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventilator NCPAP | Active Comparator | neonatal ventilator (SLE; Specialised Laboratory Equipment, UK) PEEP: 5 cmH2O |
|
| Infant Flow-driver NCPAP | Active Comparator | infant flow-driver device (Infant Flow System, Viasys Corp., USA) PEEP:5-8 cmH2O, This group receive variable flow |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ventilator NCPAP | Device | infants will be randomized into two different NCPAP groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| noninvasive ventilation failure | need for mechanical ventilation in the first 72 hours of life | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mehmet Büyüktiryaki, MD | Contact | +905054525576 | mbuyuktiryaki@yahoo.com | |
| Suna Oguz | Contact | +90 3123065270 | serifesuna@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Suna OÄŸuz | Zekai Tahir Burak Women's Health Research and Education Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zekai Tahir Burak Maternity Teaching | Recruiting | Ankara | 06230 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D007040 | Hypoventilation |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |