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New bedside scanner could detect lung problems in premature babies without X-Rays

NCT ID NCT04848727

Knowledge-focused Sponsor: Sharp HealthCare Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a device called electrical impedance tomography (EIT) can detect collapsed lung (atelectasis) or air leaks (pneumothorax) in newborn babies. Researchers placed the EIT system at the bedside of 20 infants in the NICU and compared its readings to chest X-rays. The goal was to see if EIT could reliably identify these lung problems without radiation.

What this could mean

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

What this could lead to
If successful, this could lead to a safer, radiation-free way to monitor lung problems in newborns at the bedside.
What could go wrong
This is a very small, early study with only 20 infants. It only tests if EIT can detect known problems, not whether it improves outcomes.

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.

Participants

20 people

The number who actually took part.

Started

Aug 2021

Finished

Jun 2022

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.

Who is studied

All infants admitted to the Neonatal Intensive Care Unit (NICU) at Sharp Mary Birch Hospital for Women \& Newborns with confirmed asymmetric lung disease (atelectasis or pneumothorax) by radiographic images requiring no respiratory support or on mechanical support or nCPAP therapy of 5-8 cm H20 achieved with a ventilator, an underwater "bubble" system, or a variable-flow device will be enrolled

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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. All infants admitted to the NICU at SMBHWN 2. Informed consent obtained 3. Atelectasis confirmed on CXR 4. Pneumothorax confirmed on CXR Exclusion Criteria: 1. Declined consent 2. Infants with known congenital anomalies

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Conditions

The condition(s) this trial relates to.

pneumothorax pulmonary immaturity

As listed by the trial registrant

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

Atelectasis neonatal Pneumothorax and air leak

Contacts and locations

Locations

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California, 92123, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.