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

NCT07061366 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

  • Preterm
  • Monitoring

Sponsors & Collaborators

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

    collaborator OTHER

  • Maxima Medical Center

    lead OTHER

Eligibility

Max Age
1 Week
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-10
Primary Completion
2026-07-01
Completion
2027-01-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07061366 on ClinicalTrials.gov