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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours
Other interventionchange flow from 6 to 2 LPM. Follow TcCO2 for 3 hours
change flow from 2 to 6 LPM. Follow TcCO2 for 3h
Other interventionchange flow from 2 to 6 LPM. Follow TcCO2 for 3h
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: start with 2LPMExperimental treatment 2 interventions
Group B: start with 6LPM0Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Delta CO2
the change in TcCO2
Time frame
3 hours after flow changeSponsors and contacts
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Source ClinicalTrials.gov