A Light Emitting Diode (LED) Mattress for Phototherapy of Jaundiced Newborns

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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A Light Emitting Diode (LED) Mattress for Phototherapy of Jaundiced Newborns

Conditions
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Hyperbilirubinemia, Neonatal

Intervention / Treatment
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* Device: Neolight Phototherapy Mattress
* Device: Standard-of-Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female newborns greater of equal to 28 weeks GA Parental informed consent Enrollment at age greater than 6 hrs of age until neonatal discharge Phototherapy routine order Exclusion Criteria: Infant requiring respiratory assistance (such as mechanical ventilation) Severe or life-threatening congenital anomalies Blood transfusion history

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 8 Months

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neolight Phototherapy Mattress<br>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. | Device: Neolight Phototherapy Mattress<br>* 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.<br>|
| Standard-of-Care Phototherapy<br>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. | Device: Standard-of-Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Safety of the neoLight device will be assessed as no change in an infant's temperature during phototherapy | up to 1 week |