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The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study.
Sponsor: Maxima Medical Center
Summary
This observational, non-interventional cohort study evaluates the clinical use of the Bambi Belt-a CE-certified, wireless device for non-invasive heart rate and respiration monitoring-in extremely preterm infants (\<26 weeks gestation). 15 infants with intact skin and age \<24 hours will be monitored using the Bambi Belt during the first ten days of life. Primary outcomes include ease of use (application, signal stability), skin tolerance, and user experience (nurses and parents). Standard care remains unchanged. Data will be collected via clinical records and evaluation forms.
Official title: The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study
Key Details
Gender
All
Age Range
Any - 1 Week
Study Type
OBSERVATIONAL
Enrollment
15
Start Date
2025-08-10
Completion Date
2027-01-01
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Locations (2)
Amsterdam UMC
Amsterdam, Netherlands
Maxima Medical Centre
Veldhoven, Netherlands