RecruitingNCT07061366

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

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


Sponsor

Maxima Medical Center

Enrollment

15 participants

Start Date

Aug 10, 2025

Study Type

OBSERVATIONAL

Conditions

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

Max Age: 1 Week

Exclusion Criteria1

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Locations(2)

Amsterdam UMC

Amsterdam, Netherlands

Maxima Medical Centre

Veldhoven, Netherlands

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NCT07061366


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