Actively Recruiting
The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study.
Led by Maxima Medical Center · Updated on 2026-03-11
15
Participants Needed
2
Research Sites
72 weeks
Total Duration
On this page
Sponsors
M
Maxima Medical Center
Lead Sponsor
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm born before 26 weeks
- Within the first 24 hours of life
- Skin intact with no damage
You will not qualify if you...
- Skin integrity problems prior to study
- Receiving palliative care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
2
Maxima Medical Centre
Veldhoven, Netherlands, 5504 DB
Actively Recruiting
Research Team
H
Hendrik J Niemarkt, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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