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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 7 days
Healthy Volunteers: f
View:
Locations
Other Locations
Netherlands
Maxima Medical Centre
RECRUITING
Veldhoven
Contact Information
Primary
Hendrik J Niemarkt, MD PhD
hendrik.niemarkt@mmc.nl
+31621825013
Time Frame
Start Date: 2025-08-10
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 15
Treatments
Extremely preterm infants
Related Therapeutic Areas
Sponsors
Leads: Maxima Medical Center

This content was sourced from clinicaltrials.gov