Servo-n HFOV Study: Safety and Performance in Neonates and Infants

April 20, 2026 updated by: Maquet Critical Care AB

Servo-n High-Frequency Oscillatory Ventilation in Clinical Practice: A Prospective, Observational, Single-arm and Multi-center Study

The purpose of this study is to evaluate the safety and performance of High-Frequency Oscillatory Ventilation (HFOV) modes of the Servo-n ventilator in neonates and infants, by using a prospective, observational, single-arm (i.e., non-controlled) and multi-center Post-Market Follow-up (PMCF) study design. HFOV treatment will be evaluated by assessing ventilation and oxygenation variables, and safety will be evaluated by documentation of device related adverse events.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to evaluate the safety and performance of HFOV modes of the Servo-n ventilator in neonates and infants. This is a prospective, observational, single-arm (i.e., non-controlled) and multi-center PMCF study in neonates and infants between 0.3 to 8 kg. All study procedures are within each hospital's routine clinical practice.The primary endpoints includes variables which are routinely used per clinical practice for assessing the status of patient's ventilation and oxygenation, respectively. Secondary endpoints are used to evaluate safety of Servo-n HFOV during its use by assessing rates of adverse event/ device deficiencies related to the Servo-n HFOV device, and by assessing rates of mortality, Bronchopulmonary Dysplasia (BPD) and Retinopathy at Intensive Care Unit (ICU) discharge. Data collection will take place up to 24 hours prior to HFOV treatment, during HFOV and up to ICU discharge. Additional general data such as ventilator settings, reasons for initiating/terminating HFOV treatment and demographics will also be recorded.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Montpellier, France
        • CHU Montpellier-Arnaud de Villeneuve
      • Paris, France
        • Antoine-Béclère Hospital
  • Poland
      • Poznan, Poland
        • Poznan University of Medical Sciences
  • Switzerland
      • Geneva, Switzerland
        • University Hospital of Geneva (HUG)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Servo-n HFOV treatment
As this study is single-armed (non-controlled), all patients in this study receive the same treatment, i.e. Servo-n HFOV treatment. There are however two subgroups, elective HFOV and rescue HFOV treatment
Device: Servo-n HFOV modes
Treatment with high frequency oscillatory ventilation with Servo-n device in accordance to Standard of Care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects that achieved and/or maintained target ranges for oxygenation, as measured by preductal Saturation of Peripheral Oxygen (SpO2).
Time Frame: After Servo-n HFOV treatment, expected treatment duration 1-30 days
Oxygenation response, elective HFOV patients
After Servo-n HFOV treatment, expected treatment duration 1-30 days
Proportion of subjects that achieved and/or maintained target ranges for ventilation as measured either by Partial Pressure of Carbon Dioxide (PCO2) (if available blood gas) or Transcutaneous Carbon Dioxide (TcCO2)
Time Frame: After Servo-n HFOV treatment, expected treatment duration 1-30 days
Ventilation response, elective HFOV patients
After Servo-n HFOV treatment, expected treatment duration 1-30 days
Proportion of subjects that maintained or improved values for oxygenation as measured by the SpO2/FiO2 ratio and/ or achieved target ranges for oxygenation (preductal SpO2)
Time Frame: After Servo-n HFOV treatment, expected treatment duration 1-30 days
Oxygenation response, rescue HFOV patients
After Servo-n HFOV treatment, expected treatment duration 1-30 days
Proportion of subjects that maintained or improved values, and/or achieved target ranges, for ventilation as measured either by PCO2 (if available blood gas) or TcCO2.
Time Frame: After Servo-n HFOV treatment, expected treatment duration 1-30 days
Ventilation response, rescue HFOV patients
After Servo-n HFOV treatment, expected treatment duration 1-30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The occurrence of reported Servo-n HFOV device (including accessories) deficiencies and adverse device effects and serious adverse device effects (ADE and SADE)
Time Frame: After Servo-n HFOV treatment, expected treatment duration 1-30 days
Device deficiencies and adverse events
After Servo-n HFOV treatment, expected treatment duration 1-30 days
Patient outcome at ICU discharge
Time Frame: Through study completion (at ICU discharge), expected up to 120 days
Events to be noted are: death caused by respiratory failure, death caused by circulatory failure, all-cause death, device related death, retinopathy and bronchopulmonary dysplasia
Through study completion (at ICU discharge), expected up to 120 days
Assessment of oxygenation status
Time Frame: From available blood gas and at Baseline (-4h -2h, -1h, 0h), During HFOV (0h, 30min, 1h, 2h, 4h, 6h. etc every 6 h), Post HFOV (2h, 4h, 6h, 12h and 24h)
Oxygen Saturation (SO2)
From available blood gas and at Baseline (-4h -2h, -1h, 0h), During HFOV (0h, 30min, 1h, 2h, 4h, 6h. etc every 6 h), Post HFOV (2h, 4h, 6h, 12h and 24h)
Assessment of ventilation status
Time Frame: From available blood gas and at Baseline (-4h -2h, -1h, 0h), During HFOV (0h, 30min, 1h, 2h, 4h, 6h. etc every 6 h), Post HFOV (2h, 4h, 6h, 12h and 24h)
Partial pressure of CO2 (PCO2)
From available blood gas and at Baseline (-4h -2h, -1h, 0h), During HFOV (0h, 30min, 1h, 2h, 4h, 6h. etc every 6 h), Post HFOV (2h, 4h, 6h, 12h and 24h)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maquet Critical Care AB

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NAMSA
Paediatric and Neonatal Mechanical Ventilation (PNV) Consulting

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Peter Rimensberger, Prof. MD, PNV consulting

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EVU-215176

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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