Evaluating the Safety and Performance of Servo-n HFOV in Neonates and Infants
Servo-n High-Frequency Oscillatory Ventilation in Clinical Practice: A Prospective, Observational, Single-arm and Multi-center Study
This study is testing how safe and effective a special type of breathing machine is for newborns and infants who need help with their breathing.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Sex | All |
| Sponsor | Maquet Critical Care AB Industry-sponsored |
| Locations | 4 sites (Montpellier and 3 other locations) |
| Trial ID | NCT06114992 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and performance of High-Frequency Oscillatory Ventilation (HFOV) modes using the Servo-n ventilator in neonates and infants. It employs a prospective, single-arm, multi-center design, focusing on patients weighing between 0.3 to 8 kg who require HFOV treatment. The study will monitor ventilation and oxygenation variables, as well as document any device-related adverse events. Data will be collected before, during, and after HFOV treatment, up to ICU discharge, to evaluate both efficacy and safety outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates and infants weighing between 0.3 to 8 kg who are eligible for HFOV treatment based on clinical judgment.
Not a fit: Patients who have previously undergone HFOV treatment for respiratory failure without a change in their condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of respiratory failure in neonates and infants, potentially leading to better clinical outcomes.
How similar studies have performed: While this approach is based on established HFOV techniques, the specific evaluation of the Servo-n ventilator in this population is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Montpellier and 3 other locations
- CHU Montpellier-Arnaud de Villeneuve — Montpellier, France (Recruiting)
- Antoine-Béclère Hospital — Paris, France (Recruiting)
- Poznan University of Medical Sciences — Poznan, Poland (Recruiting)
- University Hospital of Geneva (HUG), — Geneva, Switzerland (Recruiting)
Study contacts
- Study coordinator: Ylva Kai-larsen, PhD
- Email: ylva.kai-larsen@getinge.com
- Phone: +46766987269
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.