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

Study acronym: BB-EP
StatusRecruiting
PhaseNot specified
Started
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.

Record History

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  1. Study sites: 1 to 2
    • Collaborators expanded, about 8 words
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoints: 3 to 4
    • Start date changed from estimate of Jul 3, 2025 to Aug 10, 2025
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07061366
Lead Sponsor Maxima Medical Center
Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions
(from sponsor)		 Preterm, Monitoring
Related terms Premature Birth
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov