Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-01 @ 5:31 AM
Study NCT ID:
NCT07061366
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-10', 'studyFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ease of use', 'timeFrame': 'As long as belt is worn (10 days)', 'description': 'ease of application according to score of nurse.'}, {'measure': 'Skin integrity', 'timeFrame': 'as long as belt is worn (10 days)', 'description': 'any skin reactions that necessitate a switch back to conventional electrodes'}, {'measure': 'User experience', 'timeFrame': 'From belt is worn till month after', 'description': 'feedback from nurses and parents, collected through brief evaluation forms'}, {'measure': 'Signal stability', 'timeFrame': 'during 10 days (study period wearing belt)', 'description': 'Precentage of time were reliable respiratory and heart rate signal is collected'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wireless', 'monitoring', 'heart rate'], 'conditions': ['Preterm', 'Monitoring']}, 'referencesModule': {'references': [{'pmid': '37795597', 'type': 'BACKGROUND', 'citation': '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': '38400415', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nFollowing 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.\n\nThe 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:\n\nEase of use: including the ease of application, signal stability, and frequency of repositioning.\n\nSkin tolerance: assessment of any skin reactions that necessitate switching back to conventional electrodes.\n\nUser experience: qualitative feedback from nurses and parents, collected via brief evaluation forms.\n\nClinical 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).\n\nThis 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Week', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Extremely preterm infants in NICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Preterm born \\<26 weeks; first week of life -\n\nExclusion Criteria: skin integrity problems prior to study, palliative care.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07061366', 'acronym': 'BB-EP', 'briefTitle': 'The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study.', 'organization': {'class': 'OTHER', 'fullName': 'Maxima Medical Center'}, 'officialTitle': 'The Use of the Bambi-Belt in Exteremly Preterm Infants: an Implementation Study', 'orgStudyIdInfo': {'id': 'N25.024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Extremely preterm infants'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5504 DB', 'city': 'Veldhoven', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Hendrik J Niemarkt, MD pHD', 'role': 'CONTACT', 'email': 'hendrik.niemarkt@mmc.nl', 'phone': '+408889350'}], 'facility': 'Maxima Medical Centre', 'geoPoint': {'lat': 51.41833, 'lon': 5.40278}}], 'centralContacts': [{'name': 'Hendrik J Niemarkt, MD PhD', 'role': 'CONTACT', 'email': 'hendrik.niemarkt@mmc.nl', 'phone': '+31621825013'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maxima Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Hendrik Niemarkt', 'investigatorAffiliation': 'Maxima Medical Center'}}}}