New belt may help doctors fine-tune breathing machines for tiny lungs

NCT ID NCT07319624

Knowledge-focused Sponsor: Papa Giovanni XXIII Hospital Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a special belt that creates images of the lungs (Electrical Impedance Tomography) can safely help doctors choose the best pressure settings on a breathing machine for infants under 3 years old. The study included 14 children with various serious conditions like pneumonia or after liver transplant. The main goal was to see if the procedure was feasible and safe, not to prove it improves health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Electrical Impedance Tomography (EIT) belt
What this could lead to: If successful, this approach could help doctors set breathing machines more precisely for tiny children, potentially reducing lung injury.
What could go wrong: This was a very small, early feasibility study with only 14 children. It does not prove that EIT guidance improves outcomes, and the technique may not work for all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

14 people

The number who actually took part.

Started

Dec 2024

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 3 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age under 3 * Impaired oxygenation - defined as an 1. oxygenation Index (OI = mean airway pressure multiplied by FiO₂ divided by PaO₂) greater than 4; and/or 2. an Oxygen Saturation Index (OSI = mean airway pressure multiplied by FiO₂ divided by SpO₂) greater than 5; or 3. altered respiratory mechanics - defined as reduced respiratory system compliance normalized to body weight (Crs/kg) below 0.7 mL/cmH₂O/kg. Exclusion Criteria: * thoracic fractures * chest drains * subcutaneous thoracic devices * presence of intracardiac shunts * confirmed or suspected pneumothorax on chest X-ray or lung ultrasound * hemodynamic instability requiring adrenaline or noradrenaline at doses exceeding 0.05 mcg/kg/min, or a reduction in systolic blood pressure greater than 30% during recruitment maneuvers. * technical issues that prevented reliable acquisition of EIT signals, including prolonged signal instability * belt-to-chest size incompatibility (\< 3 kg) * lack of informed consent

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Conditions

The condition(s) this trial relates to.

pneumonia poisoning tetralogy of fallot

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Caustics ingestion Orthotopic liver transplantation Pneumonia Tetralogy of fallot correction

New belt may help doctors fine-tune breathing machines for tiny lungs

What the study statuses mean