An interventional study of 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 Respiratory Distress Syndrome, Prematurity and Non Invasive Ventilation, sponsored by Rambam Health Care Campus. Recruiting at 1 site in Israel. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Treatment
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.
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.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's planned enrollment of 45 is below the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Rambam Health Care Campus is the lead sponsor of 466 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
start with 2LPM
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 6LPM
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
change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours
change flow from 2 to 6 LPM. Follow TcCO2 for 3h
Delta CO2
the change in TcCO2
Time frame: 3 hours after flow change
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Respiratory Distress Syndrome →