Evaluation of the Bambi Belt for Heart and Breathing Monitoring in Extremely Preterm Infants Born Before 26 Weeks

What this Trial Is About

Researchers are evaluating the clinical use of the Bambi Belt, a CE-certified wireless device, for non-invasive monitoring of heart rate and respiration in extremely preterm infants born before 26 weeks gestation. This observational, non-interventional cohort study aims to assess the devices ease of use, skin tolerance, and user experience from nurses and parents while keeping standard care unchanged. The Bambi Belt will be applied to 15 infants with intact skin and a postnatal age under 24 hours, and will be worn continuously for the first ten days of life. During this period, the study focuses on how easy the belt is to apply, its signal stability, the frequency of repositioning, and any skin reactions that may require switching back to conventional monitoring electrodes. Feedback will be collected from nursing staff and parents using evaluation forms. Participants will be monitored using the belt while clinical data is gathered from electronic patient records. Data will be coded and handled according to privacy regulations. The study will also follow user experience up to one month after the belt is worn. The total involvement includes the initial ten days of monitoring plus follow-up for feedback, with no changes to usual care and minimal risk anticipated.

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