Elective HFOV for Respiratory Failure in Neonates/InfantsNCT06114992
Servo-n HFOV Study: Safety and Performance in Neonates and Infants
An observational study of Elective HFOV for Respiratory Failure in Neonates/Infants and Rescue HFOV in Neonates and/Infants With Refractory Respiratory Failure Under Conventional Therapy, run by Maquet Critical Care AB at 4 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Elective HFOV for Respiratory Failure in Neonates/Infants, Rescue HFOV in Neonates and/Infants With Refractory Respiratory Failure Under Conventional Therapy
- What is being tested?
- Servo-n HFOV modes
- Type of treatment
- Medical device
- How many people
- 83 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 15 Jul 2024to 3 Jul 2026
- How long will I take part?
- 120 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
France2 sites
CHU Montpellier-Arnaud de Villeneuve
Montpellier
Antoine-Béclère Hospital
Paris
About this study
Official title: 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.
Read the 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.
- Conditions
- Elective HFOV for Respiratory Failure in Neonates/Infants, Rescue HFOV in Neonates and/Infants With Refractory Respiratory Failure Under Conventional Therapy
- Being tested
- Servo-n HFOV modes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Servo-n HFOV modesDevice
Treatment with high frequency oscillatory ventilation with Servo-n device in accordance to Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Servo-n HFOV modes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects that achieved and/or maintained target ranges for oxygenation, as measured by preductal Saturation of Peripheral Oxygen (SpO2).
Oxygenation response, elective HFOV patients
Measured: 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)
Ventilation response, elective HFOV patients
Measured: 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)
Oxygenation response, rescue HFOV patients
Measured: 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.
Ventilation response, rescue HFOV patients
Measured: After Servo-n HFOV treatment, expected treatment duration 1-30 days
Secondary outcomes (4)
The occurrence of reported Servo-n HFOV device (including accessories) deficiencies and adverse device effects and serious adverse device effects (ADE and SADE)
Device deficiencies and adverse events
Measured: After Servo-n HFOV treatment, expected treatment duration 1-30 days
Patient outcome at ICU discharge
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
Measured: Through study completion (at ICU discharge), expected up to 120 days
Assessment of oxygenation status
Oxygen Saturation (SO2)
Measured: 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
Partial pressure of CO2 (PCO2)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start15 Jul 2024
- Primary completion14 Apr 2026
- Study completion3 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective HFOV for Respiratory Failure in Neonates/InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
- Target duration
- 120 Days
Sponsor and investigators
- Lead sponsor
- Maquet Critical Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA, Paediatric and Neonatal Mechanical Ventilation (PNV) Consulting
- Responsible party
- Sponsor
- Investigators
- Peter Rimensberger, Prof. MD, Study chair, PNV consulting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114992
- Sponsor's protocol ID
- EVU-215176
- Status last verified
- Jul 2026
- First submitted
- 11 Oct 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Servo-n High-Frequency Oscillatory Ventilation in Clinical Practice: A Prospective, Observational, Single-arm and Multi-center Study
- ClinicalTrials.gov ID
- NCT06114992
- Acronym / sponsor ID
- EVU-215176
- Conditions
- Elective HFOV for Respiratory Failure in Neonates/Infants, Rescue HFOV in Neonates and/Infants With Refractory Respiratory Failure Under Conventional Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Maquet Critical Care ABIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA, Paediatric and Neonatal Mechanical Ventilation (PNV) Consulting
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 3 Jul 2026 (actual)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 120 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Servo-n HFOV treatment | – | Device: Servo-n HFOV modesAs 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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:
- ; OR
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Servo-n HFOV modesTreatment with high frequency oscillatory ventilation with Servo-n device in accordance to Standard of Care | Device | Servo-n HFOV treatment |
Primary outcome
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
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
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
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
4 secondary outcomes
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
Patient outcome at ICU discharge
Time frame: 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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Rimensberger, Prof. MD study chair
PNV consulting
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elective HFOV for Respiratory Failure in Neonates/Infants and Rescue HFOV in Neonates and/Infants With Refractory Respiratory Failure Under Conventional Therapy, run by Maquet Critical Care AB at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Poland, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.