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NCT06114992

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

Recruiting now Last updated 3 April 2025
What this trial tests

trial testing Servo-n HFOV modes in Elective HFOV for Respiratory Failure in Neonates/Infants in 75 participants. Currently enrolling.

Timeline
15 July 2024
Primary endpoint
30 November 2026
31 December 2026

Quick facts

Lead sponsorMaquet Critical Care AB
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment75
Start date15 July 2024
Primary completion30 November 2026
Estimated completion31 December 2026
Sites4 locations across France, Switzerland, Poland

Drugs / interventions tested

Conditions studied

Sponsor

Maquet Critical Care AB

Who can join

Eligibility, any sex, with Elective HFOV for Respiratory Failure in Neonates/Infants or Rescue HFOV in Neonates and/Infants With Refractory Respiratory Failure Under Conventional Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06114992.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing