Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorRambam Health Care Campus
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours
- change flow from 2 to 6 LPM. Follow TcCO2 for 3h
Treatment groups
45 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov