Wireless MicroPremVitals Button Sensor in the NICU
Miniaturized Vital Sign Monitoring for Preterm Infants in the Neonatal Intensive Care Unit
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Building on prior collaborative work between the Smart Hospital Project and the Dr. John Rogers Laboratory (QSIB- Northwestern University, Chicago, USA) in skin-integrated, soft, flexible electronics for premature infants, these button-sized sensors are designed to provide continuous ECG, oxygen saturation (SpO₂), and skin temperature monitoring without the bulky wires and large adhesives that impact the most fragile infants. By miniaturizing the hardware and tailoring form factor, weight, and interface materials for fragile neonatal skin, the system aims to extend wireless, clinical-grade monitoring down to the smallest, sickest babies.
In the NICU, the possible use of wireless sensors has received positive feedback from parents and HCPs. Overall, the perception is that eliminating the wires and cables will facilitate sensors application and monitoring, improve patient comfort, and skin-to-skin contact between infants and parents.
This proposal aims to:
- Investigate the feasibility, safety, and accuracy of the Wireless MicroPremVitals Button Sensors monitoring system specifically developed for use in extremely preterm neonates.
- Assess parents and HCPs perspectives on standard and wireless vital sign monitoring systems in extremely preterm infants.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Alyssa Maximov
- Telefoonnummer: 78229 5149341934
- E-mail: alyssa.maximov@muhc.mcgill.ca
Studie Locaties
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Quebec
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Montreal, Quebec, Canada, H4A 3H9
- Werving
- Montreal Children's Hospital
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Contact:
- Alyssa Maximov
- Telefoonnummer: 78229 5149341934
- E-mail: alyssa.maximov@muhc.mcgill.ca
-
Hoofdonderzoeker:
- Guilherme Sant'Anna, MD, PhD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Infants admitted to the NICU with a gestational age of ≥ 22+0 weeks and ≤ 29+6 weeks at birth,
- AND >72h of age at time of study,
- AND clinically stable,
- AND with the Neonatal Nurse Practitioner (i.e., NNP) and Healthcare Team in agreement for the patient to participate in the study.
Exclusion Criteria:
- Infants with a skin abnormality that would potentially increase the risk of injury,
- patient too unstable or family experiencing too much stress as determined by an attending physician or bedside care team to not be approached for recruitment.
- Infants admitted to the NICU with a gestational age of < 22+0 weeks or > 29+6 weeks at birth,
- and/or ≤ 72h of age at time of study,
- and/or not meeting all requirements of clinical stability,
- and/or with the Neonatal Nurse Practitioner (i.e., NNP)/Healthcare Team in disagreement for the patient to participate in the study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Toestel Haalbaarheid
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Extremely Preterm Infant
The Wireless MicroPremVitals Button Sensor System consists of three (3) sensors: a chest unit, a forehead unit, and a limb unit. In this study, the MicroPremVitals Button forehead sensor will be mounted on the cerebral area of neonates at the level of the forehead. The chest unit will be mounted on the chest, between the nipples, or slightly below the nipple-line as placement allows. The limb unit will be mounted on the outer surface of the hand, wrist, or ankle of any limbs, as placement with standard wired equipment allows. |
These button-sized sensors are designed to provide continuous ECG, oxygen saturation (SpO₂), and skin temperature monitoring without the bulky wires and large adhesives that impact the most fragile infants.
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Experimenteel: Micro Preterm Infant
The Wireless MicroPremVitals Button Sensor System consists of three (3) sensors: a chest unit, a forehead unit, and a limb unit. In this study, the MicroPremVitals Button forehead sensor will be mounted on the cerebral area of neonates at the level of the forehead. The chest unit will be mounted on the chest, between the nipples, or slightly below the nipple-line as placement allows. The limb unit will be mounted on the outer surface of the hand, wrist, or ankle of any limbs, as placement with standard wired equipment allows. |
These button-sized sensors are designed to provide continuous ECG, oxygen saturation (SpO₂), and skin temperature monitoring without the bulky wires and large adhesives that impact the most fragile infants.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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HR Accuracy
Tijdsspanne: 6 months
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Comparison of heart rate measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.
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6 months
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Oxygen Saturation Accuracy
Tijdsspanne: 6 months
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Comparison of SpO₂ measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.
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6 months
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Skin Temperature Accuracy
Tijdsspanne: 6 months
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Comparison of skin temperature measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.
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6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Perspectives
Tijdsspanne: 6 months
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Clinician and parent/guardian perspectives on both the Wireless MicroPremVitals Button Sensor System and the wired vital sign monitoring system, will be assessed using a custom study questionnaire.
The questionnaire includes Likert-scale items, multiple-choice questions, and open-ended responses evaluating usability, perceived safety, accuracy, comfort, and acceptability.
Responses will be summarized descriptively by questionnaire item.
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6 months
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Guilherme Sant'Anna, MD, PhD, The Research Institute of the McGill University Health Center
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Pathologische processen
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Verloskundige arbeid, voortijdig
- Verloskundige arbeidscomplicaties
- Zwangerschap Complicaties
- Infecties
- Ziekten van de luchtwegen
- Sepsis
- Systemisch ontstekingsreactiesyndroom
- Ontsteking
- Ademhalingsstoornissen
- Baby, pasgeborene, ziekten
- Tekenen en symptomen, ademhaling
- Aangeboren, erfelijke en neonatale ziekten en afwijkingen
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Neonatale sepsis
- Voortijdige geboorte
- Apneu
Andere studie-ID-nummers
- Wireless MicroPremVitals
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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