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New imaging tool could help preterm babies breathe easier

NCT ID NCT06705257

Knowledge-focused Sponsor: South Tees Hospitals NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a new device called Electrical Impedance Tomography (EIT) can help doctors find the best pressure settings for breathing support in preterm babies born before 32 weeks. The goal is to prevent lung collapse and reduce lung injury. Thirty babies will be monitored with EIT while their breathing support pressure is adjusted. The study is small and early-stage, focusing on whether EIT is practical and useful in this setting.

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) device
What this could lead to
If successful, this could show that EIT is a useful tool to guide breathing support in preterm infants, potentially reducing lung injury.
What could go wrong
This is a small feasibility study with only 30 babies, so results may not apply widely. EIT is still experimental for this use.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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

22 to 32 weeks

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 1. Gestational age \<32 weeks based on mother's last menstrual period or first trimester ultrasound dating. 2. Receiving either CPAP or mechanical ventilation respiratory support. 3. Informed written consent from one of the parents. 4. Within the first two weeks of life. Investigators pragmatically chose this period, as there could be considerable lung injury after the first two weeks of life, making it difficult to test our hypothesis. Also, this time period would allow parents to settle down with their stressful preterm delivery and investigators could approach anytime within the first two weeks of life. Exclusion criteria 1. Major congenital malformations including congenital lung disease and congenital heart disease as ascertained by the medical team. 2. Infants diagnosed with pneumothorax i. 3. Receiving high frequency mechanical ventilation. 4. Infants with concerns of skin integrity.

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Conditions

The condition(s) this trial relates to.

Premature Birth respiratory distress syndrome in premature infants

As listed by the trial registrant

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

Electrical impedance tomography (EIT) Lung recruitment Positive end-expiratory pressure (PEEP) Preterm neonate

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • South Tees NHS Trust

    RECRUITING

    Middlesbrough, United Kingdom

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