Actively Recruiting

Phase Not Applicable
All Genders
NCT06622902

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

Led by Rambam Health Care Campus · Updated on 2025-11-28

45

Participants Needed

1

Research Sites

176 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Gestational age between 24.0 and 33.6 weeks
  • Stabilized high-flow nasal ventilation settings for at least 6 hours with minor changes (FiO2 ≤ 0.10, no change in flow)
  • Stable transcutaneous CO2 levels for at least 6 hours with variation ≤ 5 mmHg
  • At least 6 hours since surfactant administration
  • Parental consent obtained
Not Eligible

You will not qualify if you...

  • Flow less than 3 LPM with tcCO2-related pCO2 less than 40 mmHg
  • Flow 5 LPM or higher with tcCO2-related pCO2 greater than 60 mmHg
  • Unstable infants due to acute conditions such as sepsis, intraventricular hemorrhage, or congenital malformations

AI-Screening

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Trial Site Locations

Total: 1 location

1

Rambam Medical Center

Haifa, Israel, 31096

Actively Recruiting

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Research Team

O

Ori Hochwald, MD

CONTACT

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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