NCT07061366 The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study.
| NCT ID | NCT07061366 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maxima Medical Center |
| Condition | Preterm |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-08-10 |
| Primary Completion | 2026-07-01 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
Inclusion Criteria: Preterm born \<26 weeks; first week of life - Exclusion Criteria: skin integrity problems prior to study, palliative care. \-