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Baby breathing machine under the microscope: new study watches how it works

NCT ID NCT06114992

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Updated 4 times

Summary

This study watches how a high-frequency ventilator (Servo-n HFOV) works in real hospital use for babies with severe breathing failure. About 75 infants will be observed to see if the machine safely helps them get enough oxygen and remove carbon dioxide. The goal is to gather information, not to test a new treatment.

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

83 people

The number who actually took part.

Started

Jul 2024

Finished

Jul 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.

Who is studied

Both preterm and term (0.3-8 kg) neonatal/infant patient group requiring HFOV treatment. Subjects on elective HFOV and rescue HFOV, will be enrolled from up to 10 sites in European countries.

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: * Provision of written informed consent by the patient's legally designated representative(s) (may be obtained as deferred consent up to 24 hours after HFOV initiation: valid for both elective and rescue HFOV patients) * Patients eligible for HFOV ventilation with Servo-n: * Patient is either switched from conventional mechanical ventilation or HFOV with other device to Servo-n HFOV based on clinicians judgement (rescue HFOV). Note: the reason for the switch has to be that the patient failed to oxygenate or ventilate adequately with CMV or the other HFOV device ; OR * Patient was prior without or with any type of non-invasive respiratory support and is put on invasive HFOV treatment based on clinicians judgement (elective HFOV) * Patient has not already been on HFOV in a previous episode, unless the etiology of respiratory failure has changed during the same hospitalisation. For example, initial HFOV treatment for RDS, second HFOV episode of NARDS of any etiology (will be enrolled as a new patient case). NOTE1: When a patient failed weaning on conventional ventilation within 6 hours, requiring to be put back on HFOV it will be counted as one HFOV episode (weaning failure) NOTE2: When a patient is temporarily put on conventional ventilation for transport or a surgical intervention, and will be put back to HFOV afterwards, it will be counted as one HFOV episode (HFOV paused). * Patient has a body weight from 0.3 to 8.0 kg Exclusion Criteria: * Diagnosis of congenital diaphragmatic hernia * Severe cardiac anomaly expected to need corrective surgery or catheter-based intervention within 30 days from birth * Cyanotic heart disease * Intracranial hemorrhage, Grade III or IV * Congenital malformations with the exception of isolated lung hypoplasia * Persistent pulmonary hypertension (PPHN) with a documented shunt on the level of the foramen ovale * Bronchopulmonary Dysplasia (BPD) /Chronic Lung Disease (CLD)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Antoine-Béclère Hospital

    Paris, France

  • CHU Montpellier-Arnaud de Villeneuve

    Montpellier, France

  • Poznan University of Medical Sciences

    Poznan, Poland

  • University Hospital of Geneva (HUG)

    Geneva, Switzerland

More trials for these conditions

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