The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study.
Recruiting now
Conditions studied: Preterm, Monitoring
In brief
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.
Key facts
- Study ID
- NCT07061366
- Run by
- Maxima Medical Center
- People needed
- 15
- Starts
- 2025-08-10
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2026-03-11
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Amsterdam UMC — Amsterdam, Netherlands (enrolling)
- Maxima Medical Centre — Veldhoven, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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