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Active, Not Recruiting

NCT Number: NCT07057635

Wireless Irradiance SEnsors During Neonatal Phototherapy

Bilisensors are devices designed to measure the cumulative dose of phototherapy administered to neonates undergoing treatment for hyperbilirubinemia. The current standard of care typically involves intermittent spot measurements once a day using a handheld dosimeter that may give variable estimations. In contrast, bilisensors may enable continuous, real-time monitoring of light exposure, helping to know the total phototherapy dose received by the infant.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neonatal Hyperbilirubinemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Jaundice, Neonatal Newborn Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Phototherapy Complication

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal Children's Hospital

Montreal, Quebec, H4A 3H9, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants must be admitted to the Montreal Children's Hospital (MCH) Neonatal Intensive Care Unit (NICU)
  • Under phototherapy as clinically indicated
  • Diagnosis of indirect hyperbilirubinemia
  • Weight of >1000g at time of enrollment

Exclusion criteria

  • Any abnormal skin conditions (example: extreme dryness, desquamation, congenital skin disorders, etc.)
  • Diagnosis of direct hyperbilirubinemia
  • Weight of <1000g at time of enrollment
  • Any baby or family deemed ineligible (ex. too much stress, too unstable) by the clinical care team

Treatment and study plan

Primary outcomes

  1. Light Intensity

    Time frame: 3 Hours

    Comparison of intensity (µW/cm^2) data between the investigational device and gold-standard Light meter at 3 time points: start, 1.5 h and end.

Secondary outcomes

  1. Cumulative Dose

    Time frame: 3 Hours

    To determine the cumulative phototherapy dose (µ J/cm^2) measured with the investigational device during the study period.

  2. Data Transmission & Gaps

    Time frame: 2 Months

    Evaluation of data transmission and possible gaps from the investigational device.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Wireless Irradiance SEnsors During Neonatal Phototherapy: The WISE Clinical Study

Acronym: WISE

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 10, 2025
Registry last updated
May 8, 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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