Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extremely Preterm Infant | Weighing < 1500g at recruitment. | ||
| Late Preterm Infant | Weighing between between 1500g and 2500g at recruitment. | ||
| Term Infant | Weighing > 2500g at recruitment. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Dose | To determine the cumulative phototherapy dose (µ J/cm^2) measured with the investigational device during the study period. | 3 Hours |
| Data Transmission & Gaps | Evaluation of data transmission and possible gaps from the investigational device. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Guilherme Sant'Anna, MD, PhD | RI-MUHC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Children's Hospital | Montreal | Quebec | H4A 3H9 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D007567 | Jaundice, Neonatal |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 Months |
| D013568 | Pathological Conditions, Signs and Symptoms |