Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622902
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-06-26
Brief Title:
Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation HFNV in Preterm Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation HFNV in Preterm Infants
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 24-336 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
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 24-336 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 24-336 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 pCO2TcCO2 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 Students 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
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 24-336 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 pCO2TcCO2 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 Students 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None