Baby breathing machine under the microscope: new study watches how it works
NCT ID NCT06114992
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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83 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Jul 2026
- Lead sponsor
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Antoine-Béclère Hospital
Paris, France
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CHU Montpellier-Arnaud de Villeneuve
Montpellier, France
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Poznan University of Medical Sciences
Poznan, Poland
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University Hospital of Geneva (HUG)
Geneva, Switzerland
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Other studies related to the condition(s) this trial covers.
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- Can new home monitors keep tabs on breathing support without a clinic visit?