HFOV With Intermittent Sigh Breaths in Neonate: Carbon Dioxide Level

Not Applicable

Terminated

• Conditions: High-Frequency Ventilation

• Registration Number: NCT05682937
• Lead Sponsor: Prince of Songkla University

Brief Summary

The goal of this clinical trial is to the short-term effects of sigh breaths during High-frequency oscillatory ventilation (HFOV) in neonate undergoing mechanical ventilation. From meta-analysis, It revealed HFOV in neonates could reduce chronic lung disease or death rather than conventional ventilation.

The main question it aims to answer is: Do sigh breaths augment restoring lung volume and ventilation (CO2 level) in intubated neonate with HFOV? Participants will be applied sigh breaths (HFOV-sigh) during on HFOV. Researchers will compare HFOV-sigh mode to see if CO2 level (before-after intervention).

Detailed Description

Sample size calculation (before and after intervention: two dependent mean)

* alpha = 0.05, beta = 0.2,

* Delta = 1.9, SD. = 4.35

* Calculated sample size = 42

* increase sample size if loss follow up 20%

* Final sample size (n) = 50

Subgroup analysis for

* preterm neonates

* very preterm or very low birth weight neonates

* extremely preterm or extremely low birth weight neonates

Study Timeline

• Study First Submitted: 2022-12-26
• Study First Submitted QC: 2023-01-11
• Study Start: 2023-01-12
• Study First Posted: 2023-01-12
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-31
• Results First Submitted: 2024-09-14
• Results First Submitted QC: 2025-01-03
• Results First Posted: 2025-01-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-02
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Preterm and term neonate (gestational age 24-41 weeks) with postnatal age less than 28 days
• Already ventilated with high frequency ventilation at least 1 hours
• An umbilical or peripheral arterial catheterization was available

Exclusion Criteria

• Previous or current pulmonary air leaks (pulmonary interstitial emphysema, pneumothorax, pneumomediastinum, and pneumopericardium)
• Heterogeneous lung disease including MAS, congenital diaphragmatic hernia
• Suspected lung hypoplasia
• Suspected or confirmed intraventricular hemorrhage grade III-IV
• Suspected or confirmed hypoxic ischemic encephalopathy or 5-min Apgar score less than 3
• Hemodynamic instability despite using inotrope(s)
• Arterial pCO2 level less than 45 mm Hg or more than 70 mm Hg before intervention
• Need a new arterial puncture for samples both before and after interventions
• Moribund status
• Parents' decision not to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Arterial pCO2 Level	before sigh (baseline) and after sigh (2 hours)	ABL800 BASIC (Radiometer Medical ApS™, Denmark) analyzed all blood gas samples within 1 min after collection. The blood gas machine was auto-calibrated every 4 h by trained specialists every day.

Secondary Outcome Measures

Name	Time	Method
Oxygenation	before sigh (baseline) and after sigh (2 hours)	oxygen index (oxygen index = mean airway pressure x FiO2 / PaO2), higher scores mean a worse outcome, no unit of scale.
Mean Airway Pressure	2 hours after sigh breaths	Mean Airway Pressure (MAP), cmH2O

Trial Locations

Locations (1)

Songklanagarind Hospital, Prince of Songkla University; 🇹🇭 Hat-Yai, Songkhla, Thailand