NCT06622902 Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.
| NCT ID | NCT06622902 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rambam Health Care Campus |
| Condition | Respiratory Distress Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2023-08-16 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2023-08-16 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06622902 clinical trial?
This trial is open to participants of all sexes, studying Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06622902 currently recruiting?
Yes, NCT06622902 is actively recruiting participants. Contact the research team at ORI.HOCHWALD@GMAIL.COM for enrollment information.
Where is the NCT06622902 trial being conducted?
This trial is being conducted at Haifa, Israel.
Who is sponsoring the NCT06622902 clinical trial?
NCT06622902 is sponsored by Rambam Health Care Campus. The trial plans to enroll 45 participants.