Wireless Irradiance SEnsors During Neonatal Phototherapy

Wireless Irradiance SEnsors During Neonatal Phototherapy: The WISE Clinical Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07057635

Acronym

WISE

Enrollment

Registered

2025-07-10

Start date

2025-07-10

Completion date

2026-09-10

Last updated

2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaundice, Neonatal, Neonatal Hyperbilirubinemia, Newborn Complication, Phototherapy Complication

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Light Intensity	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

Measure	Time frame	Description
Cumulative Dose	3 Hours	To determine the cumulative phototherapy dose (µ J/cm\^2) measured with the investigational device during the study period.
Data Transmission & Gaps	2 Months	Evaluation of data transmission and possible gaps from the investigational device.

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORGuilherme Sant'Anna, MD, PhD

RI-MUHC

Outcome results