Wireless Irradiance SEnsors During Neonatal Phototherapy (WISE)

McGill University

Status: Not yet enrolling

Conditions: Phototherapy Complication; Neonatal Hyperbilirubinemia; Newborn Complication; Jaundice, Neonatal

Study type: Observational

Funder types: Other

Identifiers

NCT07057635

WISE Clinical

Details and patient eligibility

About

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.

Enrollment: 6 estimated patients

Sex: All

Volunteers: No 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

Trial design

6 participants in 3 patient groups

Extremely Preterm Infant

Description:

Weighing \< 1500g at recruitment.

Late Preterm Infant

Description:

Weighing between between 1500g and 2500g at recruitment.

Term Infant

Description:

Weighing \> 2500g at recruitment.