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

NCT ID: NCT07061366

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-10
• Study Completion Date: 2027-01-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Extremely preterm infants

No interventions assigned to this group

Eligibility Criteria

Exclusion Criteria

-

• Maximum Eligible Age: 1 Week
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maxima Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Hendrik Niemarkt

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Maxima Medical Centre

Veldhoven, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Hendrik J Niemarkt, MD PhD

Role: CONTACT

hendrik.niemarkt@mmc.nl

+31621825013

Facility Contacts

Hendrik J Niemarkt, MD pHD

Role: primary

hendrik.niemarkt@mmc.nl

+408889350

References

Scholten AWJ, Zhan Z, Niemarkt HJ, Vervoorn M, van Leuteren RW, de Jongh FH, van Kaam AH, Heuvel ERVD, Hutten GJ. Cardiorespiratory monitoring with a wireless and nonadhesive belt measuring diaphragm activity in preterm and term infants: A multicenter non-inferiority study. Pediatr Pulmonol. 2023 Dec;58(12):3574-3581. doi: 10.1002/ppul.26695. Epub 2023 Oct 5.

Reference Type: BACKGROUND

PMID: 37795597 (View on PubMed)

Lorente Flores CM, Zhan Z, Scholten AWJ, Hutten GJ, Vervoorn M, Niemarkt HJ. The Effects of a New Wireless Non-Adhesive Cardiorespiratory Monitoring Device on the Skin Conditions of Preterm Infants. Sensors (Basel). 2024 Feb 16;24(4):1258. doi: 10.3390/s24041258.

Reference Type: BACKGROUND

PMID: 38400415 (View on PubMed)

Other Identifiers

N25.024

Identifier Type: -

Identifier Source: org_study_id