Neonatal HyperbilirubinemiaWISENCT07057635
Wireless Irradiance SEnsors During Neonatal Phototherapy
An observational study of Neonatal Hyperbilirubinemia and Jaundice, Neonatal, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neonatal Hyperbilirubinemia, Jaundice, Neonatal, Phototherapy Complication
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jul 2025to 10 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Wireless Irradiance SEnsors During Neonatal Phototherapy: The WISE Clinical Study
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
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Extremely Preterm Infant | Weighing < 1500g at recruitment. | |
| Late Preterm Infant | Weighing between between 1500g and 2500g at recruitment. | |
| Term Infant | Weighing > 2500g at recruitment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Hours
Secondary outcomes (2)
Cumulative Dose
To determine the cumulative phototherapy dose (µ J/cm^2) measured with the investigational device during the study period.
Measured: 3 Hours
Data Transmission & Gaps
Evaluation of data transmission and possible gaps from the investigational device.
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start10 Jul 2025
- Primary completion10 Dec 2025
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HyperbilirubinemiaStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guilherme Sant'Anna, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Guilherme Sant'Anna, MD, PhD, Principal investigator, RI-MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057635
- Sponsor's protocol ID
- WISE Clinical
- Acronym
- WISE
- Status last verified
- May 2026
- First submitted
- 30 Jun 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wireless Irradiance SEnsors During Neonatal Phototherapy: The WISE Clinical Study
- ClinicalTrials.gov ID
- NCT07057635
- Acronym / sponsor ID
- WISE / WISE Clinical
- Conditions
- Neonatal Hyperbilirubinemia, Jaundice, Neonatal, Phototherapy Complication, Newborn Complication
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Extremely Preterm Infant | – | –Weighing < 1500g at recruitment. |
| Late Preterm Infant | – | –Weighing between between 1500g and 2500g at recruitment. |
| Term Infant | – | –Weighing > 2500g at recruitment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Light Intensity
Time frame: 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.
2 secondary outcomes
Cumulative Dose
Time frame: 3 Hours
Data Transmission & Gaps
Time frame: 2 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
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Newborn Abdominal Massage to Prevent Hyperbilirubinemia
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Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guilherme Sant'Anna, MD, PhD principal investigator
RI-MUHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Hyperbilirubinemia and Jaundice, Neonatal, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Light Intensity (time frame: 3 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.