Wireless MicroPremVitals Button Sensor in the NICU
Miniaturized Vital Sign Monitoring for Preterm Infants in the Neonatal Intensive Care Unit
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Alyssa Maximov
- Telefonnummer: 78229 5149341934
- E-post: alyssa.maximov@muhc.mcgill.ca
Studiesteder
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Quebec
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Montreal, Quebec, Canada, H4A 3H9
- Rekruttering
- Montreal Children's Hospital
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Ta kontakt med:
- Alyssa Maximov
- Telefonnummer: 78229 5149341934
- E-post: alyssa.maximov@muhc.mcgill.ca
-
Hovedetterforsker:
- Guilherme Sant'Anna, MD, PhD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Enhetens gjennomførbarhet
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
HR Accuracy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Perspectives
Tidsramme: 6 months
|
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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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Guilherme Sant'Anna, MD, PhD, The Research Institute of the McGill University Health Center
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Patologiske prosesser
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Obstetrisk arbeid, prematur
- Obstetriske arbeidskomplikasjoner
- Graviditetskomplikasjoner
- Infeksjoner
- Sykdommer i luftveiene
- Sepsis
- Systemisk inflammatorisk responssyndrom
- Betennelse
- Respirasjonsforstyrrelser
- Spedbarn, nyfødte, sykdommer
- Tegn og symptomer, luftveier
- Medfødte, arvelige og neonatale sykdommer og abnormiteter
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Neonatal sepsis
- For tidlig fødsel
- Apné
Andre studie-ID-numre
- Wireless MicroPremVitals
Legemiddel- og utstyrsinformasjon, studiedokumenter
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