Actively Recruiting
Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation in Preterm Infants
Led by Rambam Health Care Campus · Updated on 2025-11-28
45
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of different flow rates of heated, humidified high-flow nasal ventilation (HFNV) on carbon dioxide levels in preterm infants born between 24 and 33.6 weeks gestation who require respiratory support. This study aims to compare low (2 liters per minute) and high (6 liters per minute) flow rates of HFNV to understand their impact on transcutaneous CO2 (tcCO2) levels. The study is a prospective, crossover observational design conducted in a neonatal intensive care setting, focusing on respiratory distress in premature newborns. Participants will be randomly assigned to start with either 2 LPM or 6 LPM flow rates of HFNV. Each infant will be monitored over three hours with alternating flow rates to measure changes in tcCO2 and other respiratory parameters. The study will observe whether different flow rates cause significant changes in CO2 levels and will track any instances where safety limits for CO2 or oxygen saturation are exceeded. The study may stop early if unsafe conditions like severe desaturation or bradycardia occur. During the study, preterm infants will have their tcCO2 continuously monitored while undergoing HFNV at different flow settings. Researchers will collect data on respiratory function and safety indicators such as oxygen levels and heart rate. The primary outcome is the change in tcCO2 three hours after switching flow rates. Secondary outcomes include the number of study terminations due to unsafe CO2 levels or respiratory complications. The study plans to enroll 45 infants and will use statistical tests to analyze the results.
CONDITIONS
Brief Title
Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age between 24 and 33.6 weeks
- At least 6 hours of stable high flow nasal ventilation settings with minor changes allowed
- Stable transcutaneous CO2 levels with variation less than or equal to 5 mmHg for at least 6 hours
- At least 6 hours since surfactant treatment
- Parental consent given
You will not qualify if you...
- Flow less than 3 LPM with related pCO2 less than 40 mmHg
- Flow 5 LPM or higher with related pCO2 greater than 60 mmHg
- Unstable infants due to acute conditions such as sepsis or intraventricular hemorrhage
- Presence of congenital malformations
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 - 3 hours per flow rate change
Participants undergo changes in high flow nasal ventilation (HFNV) flow rates from 2 to 6 LPM or 6 to 2 LPM while monitoring transcutaneous CO2 levels.
1 treatment session with continuous monitoring for 3 hours
Trial Site Locations
Total: 1 location
1
Rambam Medical Center
Haifa, Israel, 31096
Actively Recruiting
Research Team
O
Ori Hochwald, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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