Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.
Rambam Health Care Campus
45 participants
Aug 16, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Gestational age 240 to 336.
- At least 6 hours of stabilized HFNP settings, i.e. minor changes in settings (FiO2 ≤0.10, no change in flow).
- At least 6 hours of stabilized tcCO2, i.e. ≤5 mmHg variation.
- At least 6 hours from surfactant administration.
- Parental consent
Exclusion Criteria3
- If flow is \<3 and tcCO2 related pCO2 is\<40mmHg.
- If Flow is ≥5 bpm and tcCO2 related pCO2 is\>60mmHg.
- Unstable infants due to acute conditions (sepsis. IVH), or congenital malformations.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours
change flow from 2 to 6 LPM. Follow TcCO2 for 3h
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06622902