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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Mar 1, 2026 to Dec 1, 2026
    • Study completion date: Mar 1, 2026 to Dec 31, 2026
    • Start date: Aug 16, 2024 to Aug 16, 2023
    v3
  2. Trial status: Active, Not Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Jan 2025 to Mar 1, 2026
    • Start date: Jan 1, 2024 to Aug 16, 2024
    • Study completion date: Mar 2025 to Mar 1, 2026
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06622902
Lead Sponsor Rambam Health Care Campus
Conditions
(from sponsor)		 Respiratory Distress Syndrome, Prematurity, Non Invasive Ventilation
Related terms Premature Birth, Respiratory Aspiration, Respiratory Distress Syndrome
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov