Bambi Belt heart and breathing monitoring for extremely preterm babies
The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study
Maxima Medical Center · NCT07061366
This project will try using a wireless Bambi Belt to monitor heart rate and breathing in extremely preterm infants under 26 weeks during their first ten days of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | N/A to 1 Week |
| Sex | All |
| Sponsor | Maxima Medical Center (other) |
| Locations | 2 sites (Amsterdam and 1 other locations) |
| Trial ID | NCT07061366 on ClinicalTrials.gov |
What this trial studies
This is an observational, non-interventional cohort of 15 extremely preterm infants (<26 weeks gestation, enrolled <24 hours after birth) who will be monitored with a CE-certified wireless Bambi Belt for the first ten days of life while all other care remains unchanged. The study will record ease of application, signal stability and frequency of repositioning, skin tolerance, and user experience from nurses and parents using clinical records and short evaluation forms. The Bambi Belt has been developed and validated at the center and is intended to offer non-adhesive, continuous heart rate and respiration monitoring that may reduce skin injury and improve comfort during kangaroo care. No experimental interventions are applied and decisions about switching to conventional electrodes will be made if skin reactions or signal problems occur.
Who should consider this trial
Good fit: Infants born before 26 weeks gestation, enrolled within 24 hours of birth, with intact skin and not receiving palliative care are ideal candidates.
Not a fit: Infants with pre-existing skin integrity problems, those receiving palliative care, or infants older than the enrollment window or ≥26 weeks gestation are unlikely to benefit from this implementation.
Why it matters
Potential benefit: If successful, the Bambi Belt could reduce skin irritation and improve comfort and handling while providing continuous heart and breathing monitoring for extremely preterm infants.
How similar studies have performed: The device has been developed and validated at the center and used successfully in the general neonatal population, but targeted data in extremely preterm infants are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Preterm born \<26 weeks; first week of life - Exclusion Criteria: skin integrity problems prior to study, palliative care. \-
Where this trial is running
Amsterdam and 1 other locations
- Amsterdam UMC — Amsterdam, Netherlands (RECRUITING)
- Maxima Medical Centre — Veldhoven, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Hendrik J Niemarkt, MD PhD
- Email: hendrik.niemarkt@mmc.nl
- Phone: +31621825013
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preterm, Monitoring, wireless, monitoring, heart rate