Wireless Irradiance SEnsors During Neonatal Phototherapy

NCT07057635 | Active Not Recruiting

• 1 other identifier: WISE Clinical
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 Hours

Secondary Outcomes (2)

• Cumulative Dose

  3 Hours

• Data Transmission & Gaps

  2 Months

Study Arms (3)

Extremely Preterm Infant

Weighing \< 1500g at recruitment.

Late Preterm Infant

Weighing between between 1500g and 2500g at recruitment.

Term Infant

Weighing \> 2500g at recruitment.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any micro premature, preterm or term neonate admitted to NICU undergoing phototherapy due to indirect hyperbilirubinemia will be considered for this pilot study. A convenience sample size of 6 patients will be enrolled.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal Children's Hospital

Montreal, Quebec, H4A 3H9, Canada

Location

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Jaundice, Neonatal

Condition Hierarchy (Ancestors)

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

Study Officials

• Guilherme Sant'Anna, MD, PhD

  RI-MUHC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 10, 2025
• Study Start: July 10, 2025
• Primary Completion: December 10, 2025
• Study Completion (Estimated): September 10, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)