Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.

Recruiting now · Not applicable

Conditions studied: Respiratory Distress Syndrome, Prematurity, Non Invasive Ventilation

In brief

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 facts

Study ID

NCT06622902

Run by

Rambam Health Care Campus

People needed

45

Starts

2023-08-16

Expected to finish

2026-12-31

Last updated by the study team

2025-11-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Rambam Medical Center — Haifa, Israel (enrolling)

Full record on ClinicalTrials.gov

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