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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 1
SponsorMaxima Medical Center

About this trial

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 criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

15 Participants
are grouped into 1 trial group

Sponsors and collaborators

Maxima Medical Center

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborator