Comparison of Effectiveness of Nasal CPAP and Nasal IMV in Early Rescue Surfactant Treatment in Preterm Infants
Phase 4
Completed
- Conditions
- Noninvasive Ventilation for Respiratory Distress Syndrome
- Registration Number
- NCT01741129
- Lead Sponsor
- Mehmet Yekta
- Brief Summary
The investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Gestational age 26-32 weeks
The criteria for failure were met by at least 1 of the following:
- pH: 7.10 and PaCO2: 70 mm Hg
- Recurrent apnea with >3 episodes (Prophylactic caffeine were used in all infants)
- Single episode of apnea that required bag-and-mask ventilation
- PaO2: 50 mmHg with a fraction of inspired oxygen of >0.5.
Exclusion Criteria
- Major congenital anomalies
- Presence of cardiovascular instability
- Intubation at admission to the NICU
- Consent not provided or refused
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants 3 months If infants needed invasive MV or Required a fraction of inspired oxygen of \>40% to maintain the targeted saturation of \>88% to 92%, surfactant treatment will give for respiratory distress syndrome (RDS). It means that nasal IMV or CPAP is ineffective.
- Secondary Outcome Measures
Name Time Method Complications of respiratory support 3 months respiratory insufficiency, pneumothorax
Trial Locations
- Locations (1)
Zekai Tahir Burak Maternity Teaching Hospital
🇹🇷Ankara, Turkey
Zekai Tahir Burak Maternity Teaching Hospital🇹🇷Ankara, Turkey