RecruitingNot ApplicableNCT06622902

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


Sponsor

Rambam Health Care Campus

Enrollment

45 participants

Start Date

Aug 16, 2023

Study Type

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying change flow from 2 to 6 LPM. Follow TcCO2 for 3h and change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours for people with non-invasive ventilation, prematurity, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERchange flow from 6 to 2 LPM. Follow TcCO2 for 3 hours

change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours

OTHERchange flow from 2 to 6 LPM. Follow TcCO2 for 3h

change flow from 2 to 6 LPM. Follow TcCO2 for 3h


Locations(1)

Rambam Medical Center

Haifa, Israel

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NCT06622902


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