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

Recruitingn/aAges any - 1 WeekAllMaxima Medical Center
NCT07061366 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: Preterm born \<26 weeks; first week of life - Exclusion Criteria: skin integrity problems prior to study, palliative care. \-
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What it tests

  • Not listed
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Where

2 sites
Amsterdam UMC
Amsterdam, Netherlands
Maxima Medical Centre
Veldhoven, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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