NCT07061366

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Maxima Medical Center · Academic / Other
• Sex: All
• Age: 1 Week
• Healthy volunteers: Not accepted

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.

Detailed description

The Bambi Belt is a CE-certified, wireless monitoring device designed for continuous, non-invasive measurement of heart rate and respiration in neonates. Developed and validated in our center, it offers several advantages over traditional adhesive electrodes, including reduced skin irritation, improved comfort during kangaroo care, and easier handling of the infant. These features are particularly relevant for extremely preterm infants (\<26 weeks gestation), whose skin is highly vulnerable and for whom standard electrodes often pose clinical challenges. Following a successful implementation phase in the general neonatal population, this study aims to evaluate the use of the Bambi Belt specifically in extremely preterm infants. Because of the low prevalence of this group, targeted implementation has not yet occurred. This observational cohort study will include 15 infants who meet the following inclusion criteria: gestational age \<26 weeks, postnatal age \<24 hours, and intact skin. The Bambi Belt will be used as the standard method for heart rate and respiration monitoring during the first ten days of life. All other aspects of care remain unchanged. Outcomes will focus on: Ease of use: including the ease of application, signal stability, and frequency of repositioning. Skin tolerance: assessment of any skin reactions that necessitate switching back to conventional electrodes. User experience: qualitative feedback from nurses and parents, collected via brief evaluation forms. Clinical data will be obtained from the hospital's electronic patient record system (EPD/DWH). All data will be coded and processed according to GDPR and institutional guidelines. Parents will provide informed consent, including optional consent for anonymous data sharing with the device manufacturer (Bambi Medical). This study is classified as non-WMO research, based on the minimal risk to the patient and the fact that the device is CE-marked and used within its intended purpose. The prior implementation phase has already been reviewed and approved as non-WMO by our local ethics review committee

Conditions

• Preterm
• Monitoring

Timeline

• Start date: 2025-08-10
• Primary completion: 2026-07-01
• Completion: 2027-01-01
• First posted: 2025-07-11
• Last updated: 2026-03-11

Locations

2 sites across 1 country: Netherlands