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

NCT06114992 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2026-04-21

No results posted yet for this study

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. HFOV treatment will be evaluated by assessing ventilation and oxygenation variables, and safety will be evaluated by documentation of device related adverse events.

Conditions

  • Elective HFOV for Respiratory Failure in Neonates/Infants
  • Rescue HFOV in Neonates and/Infants With Refractory Respiratory Failure Under Conventional Therapy

Interventions

DEVICE

Servo-n HFOV modes

Treatment with high frequency oscillatory ventilation with Servo-n device in accordance to Standard of Care

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Paediatric and Neonatal Mechanical Ventilation (PNV) Consulting

    collaborator UNKNOWN

  • Maquet Critical Care AB

    lead INDUSTRY

Principal Investigators

  • Peter Rimensberger, Prof. MD · PNV consulting

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-15
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • France
  • Poland
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06114992 on ClinicalTrials.gov