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

NCT07061366 | Recruiting

• 1 other identifier: N25.024
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Preterm; Monitoring

Keywords

wireless; monitoring; heart rate

Outcome Measures

Primary Outcomes (4)

• Ease of use

  ease of application according to score of nurse.

  As long as belt is worn (10 days)

• Skin integrity

  any skin reactions that necessitate a switch back to conventional electrodes

  as long as belt is worn (10 days)

• User experience

  feedback from nurses and parents, collected through brief evaluation forms

  From belt is worn till month after

• Signal stability

  Precentage of time were reliable respiratory and heart rate signal is collected

  during 10 days (study period wearing belt)

Study Arms (1)

Extremely preterm infants

Eligibility Criteria

• Age: Up to 1 Week
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Extremely preterm infants in NICU

Sponsors & Collaborators

• Maxima Medical Center: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (2)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Maxima Medical Centre

Veldhoven, 5504 DB, Netherlands

RECRUITING

Related Publications (2)

• 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.

  PMID: 37795597 BACKGROUND

• 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.

  PMID: 38400415 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Hendrik J Niemarkt, MD PhD

CONTACT

+31621825013; hendrik.niemarkt@mmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

NL (2)