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Recruiting NCT07732244

Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit

No phase Interventional Hypoxic-Ischemic Encephalopathy Congenital Heart Disease Stroke Hemorrhagic Aneurysm Cerebral

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Wireless NIRS.
Who it may be relevant to
Registry conditions: Hypoxic-Ischemic Encephalopathy, Congenital Heart Disease, Stroke Hemorrhagic, Aneurysm Cerebral. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit: a Sub-study of the Wireless NICU Study

Overview

The wireless NIRS sensor will be placed on the participant's forehead, directly underneath the INVOS wired sensor. The wireless NIRS sensor will remain in place for 4 consecutive hours, over 2 consecutive days. As standard-of-care, nursing personnel removes all sensors at every care to evaluate skin and reduce the risk of pressure sores. The wireless NIRS device will be removed and reapplied at the same time, by the research team who will annotate what time the sensor was removed, replaced, and the condition of the skin. This will be used to correlate signal disconnection with sensor care (i.e., skin checks, sensor removal, etc.).

Interventions

  • Device Wireless NIRS
    Wireless NIRS applied to participant forehead.

Primary outcome measures

  • Comparison of rStO2, data between the wireless NIRS and gold-standard wired NIRS. [Time frame: 6 months]
Secondary outcome measures (3)
  • Comparison of SpO2 and Heart Rate (HR) data between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800). [Time frame: 6 months]
  • Comparison of derived Heart Rate Variability (HRV) between the wireless NIRS and gold-standard wired vital sign monitoring system (Philips IntelliVue MX800). [Time frame: 6 months]
  • Provide a questionnaire to capture the perspectives of clinicians and patients' parents/guardians regarding use of the wireless NIRS compared to wired NIRS device. [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Infants admitted to the NICU with a gestational age of ≥ 32 weeks at the time of the monitoring
  • undergoing monitoring with the INVOS wired NIRS system.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Canada · 1 center
  • Montreal Children's Hospital — Montreal

Identifiers

NCT: NCT07732244 · Wireless NIRS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗