The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Preterm, Monitoring. Basic parameters: up to 1 Week · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study
Overview
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
Primary outcome measures
- Ease of use [Time frame: As long as belt is worn (10 days)]
- Skin integrity [Time frame: as long as belt is worn (10 days)]
- User experience [Time frame: From belt is worn till month after]
- Signal stability [Time frame: during 10 days (study period wearing belt)]
Eligibility criteria
Inclusion Criteria: Preterm born <26 weeks; first week of life -
Exclusion Criteria: skin integrity problems prior to study, palliative care.
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 2 centers
- Amsterdam UMC — Amsterdam
- Maxima Medical Centre — Veldhoven
Publications
- 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
- 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
Identifiers
NCT: NCT07061366 · N25.024