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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Extremely preterm infants in NICU
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
15 Participants
are grouped into 1 trial groupGroup A: Extremely preterm infants
Trial outcomes
Primary outcomes
1
Ease of use
ease of application according to score of nurse.
Time frame
As long as belt is worn (10 days)2
Skin integrity
any skin reactions that necessitate a switch back to conventional electrodes
Time frame
as long as belt is worn (10 days)3
User experience
feedback from nurses and parents, collected through brief evaluation forms
Time frame
From belt is worn till month after4
Signal stability
Precentage of time were reliable respiratory and heart rate signal is collected
Time frame
during 10 days (study period wearing belt)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Maxima Medical Center
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator
Source ClinicalTrials.gov