Condition: Respiratory Distress Syndrome · Prematurity · Non Invasive Ventilation · Sponsor: Rambam Health Care Campus
Background Preterm infants often need respiratory support. HFNV is a non-invasive method with benefits over CPAP, such as reduced nasal trauma and improved feeding. Aim Study the impact of low (2 LPM) vs. high (6 LPM) HFNV flow rates on CO2 levels in preterm infants. Methods Design: Prospective, crossover observational study. Participants: Preterm newborns (24-33.6 weeks' gestation) on HFNV. Procedure: Randomized flow rate adjustments, monitoring tcCO2 and other respiratory parameters over three hours. Outcomes Primary: Change in tcCO2. Secondary: Study terminations due to unsafe CO2 levels and changes in other respiratory metrics. Statistical Analysis Sample size: 45 infants. Analysis: Paired and unpaired t-tests for comparison within and between groups.
This description comes directly from the study's public registry record.
Ori Hochwald, MD · 972502062110 · ORI.HOCHWALD@GMAIL.COM
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| Rambam Medical Center | Haifa, Israel | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06622902