Changing high-flow nasal ventilation rate to see how CO2 levels respond in preterm infants
Official title: Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.
Run by Rambam Health Care Campus · NCT06622902 · Data updated 2026-11-12
This study will see if using a lower (2 LPM) versus higher (6 LPM) high-flow nasal ventilation rate changes carbon dioxide levels in preterm infants who need non-invasive breathing support.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Rambam Health Care Campus Academic / other |
| Locations | 1 site (Haifa) |
| Status | Recruiting |
| Started | August 16, 2023 |
| Main results expected | December 1, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | November 28, 2025 |
| Trial ID | NCT06622902 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are stabilized preterm infants (24.0–33.6 weeks gestation) already on HFNV with stable tcCO2 and HFNV settings for at least 6 hours and with parental consent.
✕Probably not a fit
Infants who are clinically unstable, have major congenital malformations, are outside the gestational age window, or meet the study's extreme CO2/flow exclusion thresholds are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective crossover study in preterm newborns (24 to 33.6 weeks gestation) already receiving heated, humidified high-flow nasal ventilation (HFNV). Infants are randomized to start at either 2 LPM or 6 LPM and have transcutaneous CO2 (tcCO2) and other respiratory parameters monitored over three-hour periods with alternating flow rates. The primary outcome is the change in tcCO2 between low and high flow settings, with safety stop criteria for unsafe CO2 or clinical instability. The study plans to enroll 45 infants and will use paired and unpaired t-tests to compare CO2 and other respiratory measures.
Why it matters
Potential benefit: If successful, the results could help clinicians choose HFNV flow settings that maintain safe CO2 levels while minimizing discomfort or nasal injury.
How similar studies have gone: Previous research supports HFNV as a safe non-invasive alternative to CPAP with benefits like reduced nasal trauma and improved feeding, but direct randomized crossover data specifically comparing 2 versus 6 LPM effects on tcCO2 are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Rambam Medical Center
Haifa, Israel Recruiting
Study contacts
- Study coordinator: Ori Hochwald, MD
- Email: ORI.HOCHWALD@GMAIL.COM
- Phone: 972502062110
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.