Status:
UNKNOWN
Infant Forced Oscillations Technique (iFOT)
Lead Sponsor:
University of Patras
Conditions:
Respiratory Function Tests
Respiratory Disease
Eligibility:
All Genders
1-12 years
Phase:
NA
Brief Summary
The aim of this study is the implementation of Forced Oscillations Technique (FOT) in newborns and small infants using a novel commercially available device. The objective is to assess the feasibilit...
Detailed Description
INTRODUCTION Pulmonary function testing during early infancy requires sophisticated equipment, specialized personnel and proper patient's preparation. As a result, lung function testing in newborns an...
Eligibility Criteria
Inclusion
- Newborns cared for in the NICU and well-baby nursery of the University Hospital of Patras, Greece.
- Parental written informed consent.
Exclusion
- Major respiratory, cardiovascular or other condition that does not permit FOT measurements at the predetermined time points.
- Any infectious disorder with increased risk of contamination.
- Orofacial anomalies (e.g. genetic syndromes) that do not permit proper application of the face mask.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04697251
Start Date
April 1 2021
End Date
March 1 2023
Last Update
April 28 2021
Active Locations (2)
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1
Neonatal Intensive Care Unit, University Hospital of Patras
Pátrai, Greece, 26504
2
Well-baby nursery, Department of Pediatrics, University Hospital of Patras
Pátrai, Greece, 26504