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| Name | Class |
|---|---|
| NeoLight, LLC. | UNKNOWN |
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The new investigational and FDA-approved device is named "SkyLife" and is a mattress, which uses blue LEDs as the light source similar to those used in the currently-used overhead blue LED panel devices.
The new investigational and FDA-approved device is named "SkyLife" and is a mattress, which uses blue LEDs as the light source similar to those used in the currently-used overhead blue LED panel devices. It is believed that this device will not only avoid many of the side effects when fluorescent tube lights are used, since it delivers safer, non-ultraviolet light; but may also be more effective than currently-used blankets or mattresses, which use blue halogen lamps or fluorescent tubes as light sources. The light is emitted under the baby. This study will discover if this device should be used in place of the currently-used devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neolight Phototherapy Mattress | Once a qualified patient is enrolled, he/she will be randomized to Neolight phototherapy or standard-of-care phototherapy, which is ordered by physician as part of routine. Duration of phototherapy exposure will be recorded as entered by RN in patient medical progress notes. |
| |
| Standard-of-Care Phototherapy | Once a qualified patient is enrolled, he/she will be randomized to Neolight phototherapy or standard-of-care phototherapy, which is ordered by physician as part of routine. Duration of phototherapy exposure will be recorded as entered by RN in patient medical progress notes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neolight Phototherapy Mattress | Device | Once a qualified patient is enrolled, he/she will be randomized to Neolight phototherapy or standard-of-care phototherapy, which is ordered by physician as part of routine. Duration of phototherapy exposure will be recorded as entered by RN in patient medical progress notes. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Bilirubin (TB) Levels | Efficacy of each device (neoLight and conventional devices) will be assessed as a decrease in TB levels (in mg/dL/hr) for each infant in each study group | up to 1 week |
| Duration of Phototherapy | Efficacy of each device (neoLight and conventional devices) will also be assessed as the duration (in hrs) of phototherapy for each infant in each study group. | up to 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Irradiance Stability of the neoLight Device | The performance of the neoLight will be assessed as the stability of irradiance emitted by the neoLight device during the use of the device | 1 year |
| Infant Temperature Change |
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Inclusion Criteria:
Exclusion Criteria:
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All infants (not gender or racial/ethnically based) equal or greater than 28 weeks GA and great than 6 hrs of age until hospital discharge.
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| Name | Affiliation | Role |
|---|---|---|
| Ronald J Wong, MD | Investigator | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States |
Sharable statistical data in regards to efficacy of device compared to Standard-of-care devices already used in a hospital setting.
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| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
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| Standard-of-Care | Device | Once a qualified patient is enrolled, he/she will be randomized to Neolight phototherapy or standard-of-care phototherapy, which is ordered by physician as part of routine. Duration of phototherapy exposure will be recorded as entered by RN in patient medical progress notes. |
|
Safety of the neoLight device will be assessed as no change in an infant's temperature during phototherapy
| up to 1 week |
| D013568 | Pathological Conditions, Signs and Symptoms |