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New lung monitor for tiny babies shows promise in early test

NCT ID NCT06917326

Knowledge-focused Sponsor: Neola Medical AB 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new device called Neola® that monitors the lungs of newborn babies. Ten preterm and term infants were enrolled to see if the device is safe and works well. The main goal was to check for any skin reactions or other side effects.

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

10 people

The number who actually took part.

Started

May 2025

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

1 day to 14 days

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: * Preterm or term born neonates with gestational age between 28 and 40 weeks * Post-natal age between 1 and 14 days * Weight between 1000 g and 3000 g * Signed informed consent prior to any study related procedures by the legal representatives of the patient * Legal representatives are 18 years or older * Legal representatives can absorb and understand the content of the informed consent form Exclusion criteria: * Known cardiopulmonary congenital anomalies * Patients with trisomies or other chromosomal abnormality * Patients not expected to survive * Non-intact skin or other skin conditions (such as skin lesions) that do not allow the use of skin adhesives. (e.g., Bullous impetigo, Staphylococcal scalded skin syndrome, localized lesions of herpes simplex virus) * Thorax curvature does not allow placement of the probe sets without air between the surface of the probes and the skin.

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Conditions

The condition(s) this trial relates to.

lung disorder 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.

Lung diseases Preterm birth RDS of prematurity

Contacts and locations

Locations

  • Södra Älvsborgs Sjukhus

    Borås, Sweden, 501 82, Sweden

More trials for these conditions

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