Wireless MicroPremVitals Button Sensor in the NICU
Miniaturized Vital Sign Monitoring for Preterm Infants in the Neonatal Intensive Care Unit
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Alyssa Maximov
- Telefonnummer: 78229 5149341934
- E-Mail: alyssa.maximov@muhc.mcgill.ca
Studienorte
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Quebec
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Montreal, Quebec, Kanada, H4A 3H9
- Rekrutierung
- Montreal Children's Hospital
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Kontakt:
- Alyssa Maximov
- Telefonnummer: 78229 5149341934
- E-Mail: alyssa.maximov@muhc.mcgill.ca
-
Hauptermittler:
- Guilherme Sant'Anna, MD, PhD
-
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Machbarkeit des Geräts
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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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Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
HR Accuracy
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Perspectives
Zeitfenster: 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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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Guilherme Sant'Anna, MD, PhD, The Research Institute of the McGill University Health Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Pathologische Prozesse
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Geburtshilfe, Frühgeburt
- Geburtsbedingte Geburtskomplikationen
- Schwangerschaftskomplikationen
- Infektionen
- Erkrankungen der Atemwege
- Sepsis
- Systemisches Entzündungsreaktionssyndrom
- Entzündung
- Atemstörungen
- Säugling, Neugeborenes, Krankheiten
- Anzeichen und Symptome, Atmung
- Angeborene, erbliche und neonatale Krankheiten und Anomalien
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Neonatale Sepsis
- Frühgeburt
- Apnoe
Andere Studien-ID-Nummern
- Wireless MicroPremVitals
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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