Clinical Trial

The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study.

Study acronym: BB-EP
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated March 11, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-07-02; most recent amendment 2026-03-09.
Status change: Not Yet Recruiting → Recruiting 2025-08-10
Trial Details
NCT Number NCT07061366
Lead Sponsor Maxima Medical Center
Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions Preterm, Monitoring
Enrollment 15 participants
Start Date 2025-08-10
Primary Completion 2026-07-01 (estimated)
Study Completion 2027-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-11