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

RECRUITINGSponsored by Maxima Medical Center
Actively Recruiting
SponsorMaxima Medical Center
Started2025-08-10
Est. completion2026-07-01
Eligibility
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07061366

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

Healthy volunteers accepted
Inclusion Criteria: Preterm born \<26 weeks; first week of life -

Exclusion Criteria: skin integrity problems prior to study, palliative care.

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Conditions3

Heart DiseaseMonitoringPreterm

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