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Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.

RecruitingNAAges 0 Minutes - 44 WeeksAllVilnius University
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In plain words

What the trial is, and whether it could suit you

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 to compare different respiratory support mode performance in different gestational age groups. Primary endpoint is treatment failure. With this study, the following hypotheses will be tested: Hypothesis 1: NIPPV has a lower failure rate compared to CPAP mode. Hypothesis 2: NIPPV complication rate is non-superior compared to CPAP.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. gestational age (GA) between 22+0 and 34+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings). 2. Need of respiratory support (deemed by a clinician). Exclusion Criteria: 1. Major congenital anomalies 2. Cardiovascular instability 3. Consent refused or not provided
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What it tests

  • NIPPV
  • CPAP
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Where

1 site
Vilnius University Santaros Klinikos
Vilnius, Lithuania
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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