Wireless Irradiance SEnsors During Neonatal Phototherapy

N/AActive Not RecruitingNCT07057635

McGill University Health Centre/Research Institute of the McGill University Health Centre9 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Neonatal Hyperbilirubinemia Jaundice, Neonatal Phototherapy Complication Newborn Complication

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Light Intensity

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.

Time frame: 3 Hours

Secondary Outcomes

Cumulative Dose

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

Time frame: 3 Hours

Data Transmission & Gaps

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

Time frame: 2 Months