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

NCT ID: NCT06622902

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-16
• Study Completion Date: 2026-12-31

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.

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.

Conditions

Respiratory Distress Syndrome; Prematurity; Non Invasive Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

start with 2LPM

start with 2LPM

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

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

Intervention Type: OTHER

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

start with 6LPM0

start with 6LPM

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

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

Intervention Type: OTHER

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

Interventions

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

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

Intervention Type: OTHER

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

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

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Ori Hochwald , MD

Head, NICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rambam Medical Center

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ori Hochwald, MD

Role: CONTACT

ORI.HOCHWALD@GMAIL.COM

972502062110

Facility Contacts

Ori Hochwald, MD

Role: primary

o_hochwald@rambam.health.gov.il

972-4-7774111

Other Identifiers

RMB059422

Identifier Type: -

Identifier Source: org_study_id