TerminatedNot Applicable

HFOV With Intermittent Sigh Breaths in Neonate: Carbon Dioxide Level

Stopped: The duration of study was planned only 1 year owing to time constraints. Although the targeted sample size was not achieved, but the results showed significant difference between two interventions.

Thailand30 participantsStarted 2023-01-12

Plain-language 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).

Who can participate

Age range1 Day – 28 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Arterial pCO2 Level

Timeframe: before sigh (baseline) and after sigh (2 hours)

Trial details

NCT IDNCT05682937

SponsorPrince of Songkla University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

Results submitted2024-09-14