Clinical Trial

Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.

Recruiting
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-10-01; most recent amendment 2025-11-26.
Status change: Active, Not Recruiting → Recruiting 2025-11-23
Trial Details
NCT Number NCT06622902
Lead Sponsor Rambam Health Care Campus
Conditions Respiratory Distress Syndrome, Prematurity, Non Invasive Ventilation
Enrollment 45 participants
Start Date 2023-08-16
Primary Completion 2026-12-01 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-28