Wireless Irradiance SEnsors During Neonatal Phototherapy

NCT ID: NCT07057635

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-10

Study Completion Date

2025-09-10

Brief Summary

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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.

Detailed Description

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Conditions

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Neonatal Hyperbilirubinemia Jaundice, Neonatal Phototherapy Complication Newborn Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Extremely Preterm Infant

Weighing \< 1500g at recruitment.

No interventions assigned to this group

Late Preterm Infant

Weighing between between 1500g and 2500g at recruitment.

No interventions assigned to this group

Term Infant

Weighing \> 2500g at recruitment.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Guilherme Sant'Anna, MD

Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guilherme Sant'Anna, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

RI-MUHC

Central Contacts

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Alyssa Maximov, BSc

Role: CONTACT

5149341934 ext. 78229

Other Identifiers

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WISE Clinical

Identifier Type: -

Identifier Source: org_study_id

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