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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Israel
Rambam Medical Center
RECRUITING
Haifa
Contact Information
Primary
Ori Hochwald, MD
ORI.HOCHWALD@GMAIL.COM
972502062110
Time Frame
Start Date: 2023-08-16
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 45
Treatments
Experimental: start with 2LPM
start with 2LPM
Experimental: start with 6LPM0
start with 6LPM
Related Therapeutic Areas
Sponsors
Leads: Rambam Health Care Campus

This content was sourced from clinicaltrials.gov