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Study identifier: NCT07061366 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Preterm · Monitoring  ·  Sponsor: Maxima Medical Center

PhaseN/A
Planned participants15
Who can joinAll sexes, N/A to 1 Week
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Hendrik J Niemarkt, MD PhD  ·  +31621825013  ·  hendrik.niemarkt@mmc.nl

Always discuss trial participation with your own doctor first.

Locations (2)

Amsterdam UMCAmsterdam, NetherlandsRecruiting
Maxima Medical CentreVeldhoven, NetherlandsRecruiting

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Source record: clinicaltrials.gov/study/NCT07061366