Respiratory Distress SyndromeNCT06622902
Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.
A study testing change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours and change flow from 2 to 6 LPM. Follow TcCO2 for 3h in people with Respiratory Distress Syndrome and Prematurity, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress Syndrome, Prematurity, Non Invasive Ventilation
- What is being tested?
- change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours and change flow from 2 to 6 LPM. Follow TcCO2 for 3h
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- 16 Aug 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Rambam Medical Center
Haifa, 31096
Ori Hochwald, MD, 972-4-7774111, o_hochwald@rambam.health.gov.il
About this study
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.
Read more
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.
Read the detailed description
Background:
Preterm Births: About 10% of births are preterm, with infants at risk for respiratory distress.
Respiratory Support: Endotracheal ventilation has improved survival but increased the risk of bronchopulmonary dysplasia.
Non-Invasive Support: Nasal CPAP minimizes complications. Heated, humidified high-flow nasal ventilation (HFNV) is an alternative, providing advantages like reduced nasal trauma and improved oral feeding.
Aim:
Primary Goal: Examine changes in transcutaneous CO2 (tcCO2) levels in preterm infants when using HFNV at low (2 LPM) versus high (6 LPM) flow rates.
Hypothesis: Different HFNV flow rates will show minimal change in tcCO2 (≤5 mmHg).
Methods:
Design: Prospective, crossover observational study in Rambam NICU. Participants: Preterm newborns (24-33.6 weeks' gestation) needing HFNV. Inclusion Criteria: Stabilized HFNP settings and tcCO2, parental consent. Exclusion Criteria: Specific flow and CO2 levels, unstable conditions, or congenital malformations.
Procedure: Randomize infants into two groups starting with 2 or 6 LPM flow rates, monitoring tcCO2 over three consecutive hours with alternating flow rates.
Measurements:
Primary Outcome: Change in tcCO2 levels. Secondary Outcomes: Number of study terminations due to pCO2/TcCO2 out of safety range, changes in respiratory parameters, and episodes of desaturation or bradycardia.
Statistical Analysis:
Sample Size: 45 infants needed to detect no difference with 90% power and 5% significance level.
Data Analysis: Use paired and unpaired Student's t-tests to compare results within and between groups.
Safety Protocol: The study will terminate if significant desaturation, bradycardia, or pCO2 levels outside the safety range occur.
- Being tested
- change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours, change flow from 2 to 6 LPM. Follow TcCO2 for 3h
- Keywords
- Respiratory distress syndrome, prematurity, HIGH FLOW, CO2, VENTILATION
- Medical subject headings
- Respiratory Distress Syndrome, Premature Birth, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
change flow from 6 to 2 LPM. Follow TcCO2 for 3 hoursOther
change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours
change flow from 2 to 6 LPM. Follow TcCO2 for 3hOther
change flow from 2 to 6 LPM. Follow TcCO2 for 3h
| Study group | Role | What they receive |
|---|---|---|
| start with 2LPM | Experimental | start with 2LPM Receives: Other: change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours; Other: change flow from 2 to 6 LPM. Follow TcCO2 for 3h |
| start with 6LPM0 | Experimental | start with 6LPM Receives: Other: change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours; Other: change flow from 2 to 6 LPM. Follow TcCO2 for 3h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta CO2
the change in TcCO2
Measured: 3 hours after flow change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start16 Aug 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ori Hochwald , MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622902
- Sponsor's protocol ID
- RMB059422
- Status last verified
- Nov 2025
- First submitted
- 26 Jun 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.
- ClinicalTrials.gov ID
- NCT06622902
- Acronym / sponsor ID
- RMB059422
- Keywords
- Respiratory distress syndrome, prematurity, HIGH FLOW, CO2, VENTILATION
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Preterm Births: About 10% of births are preterm, with infants at risk for respiratory distress.
Respiratory Support: Endotracheal ventilation has improved survival but increased the risk of bronchopulmonary dysplasia.
Non-Invasive Support: Nasal CPAP minimizes complications. Heated, humidified high-flow nasal ventilation (HFNV) is an alternative, providing advantages like reduced nasal trauma and improved oral feeding.
Aim:
Primary Goal: Examine changes in transcutaneous CO2 (tcCO2) levels in preterm infants when using HFNV at low (2 LPM) versus high (6 LPM) flow rates.
Hypothesis: Different HFNV flow rates will show minimal change in tcCO2 (≤5 mmHg).
Methods:
Design: Prospective, crossover observational study in Rambam NICU. Participants: Preterm newborns (24-33.6 weeks' gestation) needing HFNV. Inclusion Criteria: Stabilized HFNP settings and tcCO2, parental consent. Exclusion Criteria: Specific flow and CO2 levels, unstable conditions, or congenital malformations.
Procedure: Randomize infants into two groups starting with 2 or 6 LPM flow rates, monitoring tcCO2 over three consecutive hours with alternating flow rates.
Measurements:
Primary Outcome: Change in tcCO2 levels. Secondary Outcomes: Number of study terminations due to pCO2/TcCO2 out of safety range, changes in respiratory parameters, and episodes of desaturation or bradycardia.
Statistical Analysis:
Sample Size: 45 infants needed to detect no difference with 90% power and 5% significance level.
Data Analysis: Use paired and unpaired Student's t-tests to compare results within and between groups.
Safety Protocol: The study will terminate if significant desaturation, bradycardia, or pCO2 levels outside the safety range occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| start with 2LPM | Experimental | Other: change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours, Other: change flow from 2 to 6 LPM. Follow TcCO2 for 3hstart with 2LPM |
| start with 6LPM0 | Experimental | Other: change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours, Other: change flow from 2 to 6 LPM. Follow TcCO2 for 3hstart with 6LPM |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| change flow from 6 to 2 LPM. Follow TcCO2 for 3 hourschange flow from 6 to 2 LPM. Follow TcCO2 for 3 hours | Other | start with 2LPM, start with 6LPM0 |
| change flow from 2 to 6 LPM. Follow TcCO2 for 3hchange flow from 2 to 6 LPM. Follow TcCO2 for 3h | Other | start with 2LPM, start with 6LPM0 |
Primary outcome
Delta CO2
Time frame: 3 hours after flow change
the change in TcCO2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours and change flow from 2 to 6 LPM. Follow TcCO2 for 3h in people with Respiratory Distress Syndrome and Prematurity, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ori Hochwald, MD (972502062110, ORI.HOCHWALD@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta CO2 (time frame: 3 hours after flow change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.