Actively Recruiting
Randomized Control Trial Comparing Nasal CPAP and NIPPV in Preterm Infants With Respiratory Distress Syndrome
Led by Vilnius University · Updated on 2025-05-13
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two non-invasive breathing support methods, Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV), in preterm newborns with respiratory distress syndrome. The study aims to compare how these methods perform in different gestational age groups, focusing mainly on the rate of treatment failure. Treatment failure includes severe breathing difficulties, respiratory acidosis, frequent apnea episodes, or worsening respiratory severity scores. The trial includes two groups of preterm infants receiving either CPAP or NIPPV. CPAP is provided at a pressure of 6-8 mmH2O, while NIPPV settings include specific pressures and breathing rates adjusted according to gestational age. The study will monitor the infants during their respiratory support to test if NIPPV results in fewer treatment failures and to compare complication rates between the two methods. Participants will be closely monitored for treatment failure within 7 days, as well as secondary outcomes like mortality, intubation, infection rates, and complications such as lung and nasal injuries. Researchers will assess these outcomes up to 44 weeks corrected gestational age. The study involves randomized assignment to treatment groups, with ongoing evaluations to track respiratory status and any side effects during the intervention period.
CONDITIONS
Brief Title
Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age between 22 weeks 0 days and 34 weeks 6 days based on postmenstrual dating and early ultrasound.
- Need for respiratory support as determined by a clinician.
You will not qualify if you...
- Presence of major congenital anomalies.
- Cardiovascular instability.
- Consent not provided or refused.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive either nasal Continuous Positive Airway Pressure (CPAP) or Non-Invasive Positive Pressure Ventilation (NIPPV) to support breathing.
Continuous respiratory support during treatment period with regular clinical assessments
Duration - Up to 37 weeks depending on gestational age at birth
Participants are monitored for secondary outcomes including complications and health status until 44 weeks corrected gestational age.
Regular visits until 44 weeks corrected gestational age
Trial Site Locations
Total: 1 location
1
Vilnius University Santaros Klinikos
Vilnius, Vilnius County, Lithuania, 08661
Actively Recruiting
Research Team
A
Arunas Liubsys, Associate Professor
E
Ernestas Virsilas
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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