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Clinical Trials in Israel / NCT06622902
Recruiting Not applicable

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

NCT06622902 · tracked via the Priya Life Science Israel tracker
Sponsor
Rambam Health Care Campus
Phase
Not applicable
Started
2023-08-16
Last updated
2025-11-28

Condition(s) studied

Respiratory Distress SyndromePrematurityNon Invasive Ventilation

Investigational drug(s) / intervention(s)

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

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

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

Study 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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion criteria: * 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 Exclusion criteria: * 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.

Primary outcome measure(s)

  • Delta CO2 — 3 hours after flow change
    the change in TcCO2

Trial sites (1)

FacilityCityRegionStatus
Rambam Medical Center Haifa Israel Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06622902 on ClinicalTrials.gov ↗ ← All trials in Israel