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 range

1 Day – 28 Days

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More High-Frequency Ventilation trials