PretermBB-EPNCT07061366
The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study.
An observational study of Preterm and Monitoring, run by Maxima Medical Center at 2 sites in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 1 week
- Conditions the study is for
- Preterm, Monitoring
- How many people
- 15 participants
- Where
- 2 sitesNetherlands
- Study dates
- 10 Aug 2025to 1 Jan 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 week
- All sexes
- No healthy volunteers
- Child
Study population: Extremely preterm infants in NICU
Inclusion Criteria: Preterm born <26 weeks; first week of life -
Exclusion Criteria: skin integrity problems prior to study, palliative care.
-
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Gerard J Hutten, MD, PhD, +3120 - 566 9111, g.j.hutten@amsterdamumc.nl
Gerard J Hutten, MD PhD
- Recruiting
Maxima Medical Centre
Veldhoven, 5504 DB
Hendrik J Niemarkt, MD pHD, +408889350, hendrik.niemarkt@mmc.nl
About this study
Official title: The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study
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.
Read the 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
- Keywords
- wireless, monitoring, heart rate
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Extremely preterm infants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of use
ease of application according to score of nurse.
Measured: As long as belt is worn (10 days)
Skin integrity
any skin reactions that necessitate a switch back to conventional electrodes
Measured: as long as belt is worn (10 days)
User experience
feedback from nurses and parents, collected through brief evaluation forms
Measured: From belt is worn till month after
Signal stability
Precentage of time were reliable respiratory and heart rate signal is collected
Measured: during 10 days (study period wearing belt)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start10 Aug 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PretermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Maxima Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hendrik Niemarkt, Maxima Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061366
- Sponsor's protocol ID
- N25.024
- Acronym
- BB-EP
- Status last verified
- Mar 2026
- First submitted
- 2 Jul 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 37795597Lorente 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.
PubMed 38400415
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study
- ClinicalTrials.gov ID
- NCT07061366
- Acronym / sponsor ID
- BB-EP / N25.024
- Conditions
- Preterm, Monitoring
- Keywords
- wireless, monitoring, heart rate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extremely preterm infants | – | – |
Who may qualify
- Ages
- Up to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Extremely preterm infants in NICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ease of use
Time frame: As long as belt is worn (10 days)
ease of application according to score of nurse.
Skin integrity
Time frame: as long as belt is worn (10 days)
any skin reactions that necessitate a switch back to conventional electrodes
User experience
Time frame: From belt is worn till month after
feedback from nurses and parents, collected through brief evaluation forms
Signal stability
Time frame: during 10 days (study period wearing belt)
Precentage of time were reliable respiratory and heart rate signal is collected
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Background: PubMed 37795597Scholten 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.
- Background: PubMed 38400415Lorente 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.
- Individual participant dataSharing planned: Undecided
Related trials for Preterm
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm and Monitoring, run by Maxima Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hendrik J Niemarkt, MD PhD (+31621825013, hendrik.niemarkt@mmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of use (time frame: As long as belt is worn (10 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07061366, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.