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NCT Number: NCT07732257

Wireless MicroPremVitals Button Sensor in the NICU

A wireless and miniaturized vital sign (ECG, SpO2, Skin Temperature) sensor system, MicroPremVitals Button Sensors was developed by the Dr. John Rogers Laboratory (QSIB- Northwestern University, Chicago, USA) to facilitate vital sign monitoring in extremely preterm neonates.

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Key information

Conditions

Premature Birth Apnea Apnea of Prematurity Bradycardia Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fragility Infant, Newborn, Diseases Infections Inflammation Neonatal Sepsis Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Respiration Disorders Respiratory Tract Diseases Sepses, Neonatal Sepsis Signs and Symptoms Signs and Symptoms, Respiratory Systemic Inflammatory Response Syndrome Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Children's Hospital

Montreal, Quebec, H4A 3H9, Canada

Location status: Recruiting

Location contact

Alyssa Maximov

CONTACT

[email protected]

5149341934 ext. 78229

Guilherme Sant'Anna, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wireless MicroPremVitals Button Sensor System

Device

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.

Primary outcomes

  1. HR Accuracy

    Time frame: 6 months

    Comparison of heart rate measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.

  2. Oxygen Saturation Accuracy

    Time frame: 6 months

    Comparison of SpO₂ measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.

  3. Skin Temperature Accuracy

    Time frame: 6 months

    Comparison of skin temperature measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.

Secondary outcomes

  1. Perspectives

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alyssa Maximov

CONTACT

[email protected]

5149341934 ext. 78229

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Collaborators

  • Northwestern Querrey Simpson Institute for Bioelectronics (QSIB)

Registry information

Official study title

Miniaturized Vital Sign Monitoring for Preterm Infants in the Neonatal Intensive Care Unit

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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