Bambi Belt heart and breathing monitoring for extremely preterm babies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria: Preterm born \<26 weeks; first week of life -

Exclusion Criteria: skin integrity problems prior to study, palliative care.

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Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.