Status:
RECRUITING
Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.
Lead Sponsor:
Vilnius University
Conditions:
Respiratory Distress Syndrome (RDS)
Eligibility:
All Genders
Up to 44 years
Phase:
NA
Brief Summary
Primary objective: to evaluate safety and efficacy of two different non-invasive respiratory support modalities in preterm neonatal patients with respiratory distress syndrome. Secondary objective is...
Detailed Description
Treatment failure is defined as any of the following: * FiO2\>0.6 to maintain SpO2\>88% * Respiratory acidosis (pH\<7.2, pCO2\>65 mmHg) * recurrent apnea (\>4 episodes/h) or apnea requiring bag and m...
Eligibility Criteria
Inclusion
- gestational age (GA) between 22+0 and 34+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings).
- Need of respiratory support (deemed by a clinician).
Exclusion
- Major congenital anomalies
- Cardiovascular instability
- Consent refused or not provided
Key Trial Info
Start Date :
March 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06966752
Start Date
March 25 2025
End Date
May 1 2027
Last Update
May 13 2025
Active Locations (1)
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1
Vilnius University Santaros Klinikos
Vilnius, Vilnius County, Lithuania, 08661