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Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.
Sponsor: Rambam Health Care Campus
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.
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2023-08-16
Completion Date
2026-12-31
Last Updated
2025-11-28
Healthy Volunteers
No
Interventions
change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours
change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours
change flow from 2 to 6 LPM. Follow TcCO2 for 3h
change flow from 2 to 6 LPM. Follow TcCO2 for 3h
Locations (1)
Rambam Medical Center
Haifa, Israel