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

NCT06622902 | Recruiting

• 1 other identifier: RMB059422
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome; Prematurity; Non Invasive Ventilation

Keywords

Respiratory distress syndrome; prematurity; HIGH FLOW; CO2; VENTILATION

Outcome Measures

Primary Outcomes (1)

• Delta CO2

  the change in TcCO2

  3 hours after flow change

Study Arms (2)

start with 2LPM

EXPERIMENTAL

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 6LPM0

EXPERIMENTAL

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

Interventions

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

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

start with 2LPM; start with 6LPM0

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

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

start with 2LPM; start with 6LPM0

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, 31096, Israel

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Premature Birth; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ori Hochwald, MD

CONTACT

972502062110; ORI.HOCHWALD@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, NICU

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: October 2, 2024
• Study Start: August 16, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

IL (1)