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RECRUITING
NCT07061366

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

Sponsor: Maxima Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - 1 Week

Study Type

OBSERVATIONAL

Enrollment

15

Start Date

2025-08-10

Completion Date

2027-01-01

Last Updated

2026-03-11

Healthy Volunteers

No

Locations (2)

Amsterdam UMC

Amsterdam, Netherlands

Maxima Medical Centre

Veldhoven, Netherlands