Status:
RECRUITING
Servo-n HFOV Study: Safety and Performance in Neonates and Infants
Lead Sponsor:
Maquet Critical Care AB
Collaborating Sponsors:
NAMSA
Paediatric and Neonatal Mechanical Ventilation (PNV) Consulting
Conditions:
Elective HFOV for Respiratory Failure in Neonates/Infants
Rescue HFOV in Neonates and/Infants With Refractory Respiratory Failure Under Conventional Therapy
Eligibility:
All Genders
Brief 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, ob...
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-control...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06114992
Start Date
July 15 2024
End Date
December 31 2026
Last Update
April 3 2025
Active Locations (4)
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1
CHU Montpellier-Arnaud de Villeneuve
Montpellier, France
2
Antoine-Béclère Hospital
Paris, France
3
Poznan University of Medical Sciences
Poznan, Poland
4
University Hospital of Geneva (HUG),
Geneva, Switzerland