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Clinical Trials in the Netherlands / NCT07061366
Recruiting Observational

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

NCT07061366 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Maxima Medical Center
Phase
Observational
Started
2025-08-10
Last updated
2026-03-11

Condition(s) studied

PretermMonitoring

Study 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

Sex
ALL
Min age
—
Max age
1 Week
Healthy volunteers
No
Inclusion Criteria: Preterm born \<26 weeks; first week of life - Exclusion Criteria: skin integrity problems prior to study, palliative care. \-

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Amsterdam UMC Amsterdam Netherlands Recruiting
Maxima Medical Centre Veldhoven Netherlands Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07061366 on ClinicalTrials.gov ↗ ← All trials in the Netherlands