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Search / Trial NCT07061366

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

Launched by MAXIMA MEDICAL CENTER · Jul 2, 2025

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Wireless Monitoring Heart Rate

ClinConnect Summary

This study is looking at how well a new device called the Bambi Belt works for monitoring very early premature babies—those born before 26 weeks of pregnancy. The Bambi Belt is a wireless, gentle strap that can measure a baby’s heart rate and breathing without sticking to the skin. Researchers want to see how easy it is to use, how well it stays in place, how the baby’s skin reacts, and what nurses and parents think about it. The babies will still get their usual care while wearing the belt.

Babies who are less than 24 hours old, born before 26 weeks, and have healthy skin may be able to take part. The study will follow 15 babies during their first 10 days of life. The Bambi Belt will be put on and checked regularly, but it won’t change the regular care the babies receive. Families can expect the staff to collect information from medical records and ask for feedback about the device. Babies with skin problems or those receiving comfort-only care won’t be included. This study aims to understand if the Bambi Belt is a safe and helpful tool for caring for the smallest and most fragile newborns.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria: Preterm born \<26 weeks; first week of life -
  • Exclusion Criteria: skin integrity problems prior to study, palliative care.
  • -

About Maxima Medical Center

Maxima Medical Center is a leading healthcare institution dedicated to advancing medical knowledge and improving patient care through innovative clinical research. With a commitment to excellence, the center conducts a diverse range of clinical trials across various therapeutic areas, collaborating with healthcare professionals and researchers to facilitate the development of new treatments and therapies. Maxima Medical Center prioritizes patient safety and ethical standards, ensuring that all clinical studies adhere to rigorous regulatory requirements. By fostering a culture of collaboration and innovation, the center aims to contribute significantly to the medical community and enhance the quality of life for patients.

Locations

Veldhoven, , Netherlands

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported