Hyperbilirubinemia, Neonatal
Conditions
Brief summary
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
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.
Interventions
DEVICENeolight 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.
DEVICEStandard-of-Care
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.
Sponsors
NeoLight, LLC.
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 8 Months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Bilirubin (TB) Levels | up to 1 week | 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 |
| Duration of Phototherapy | up to 1 week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Irradiance Stability of the neoLight Device | 1 year | The performance of the neoLight will be assessed as the stability of irradiance emitted by the neoLight device during the use of the device |
| Infant Temperature Change | up to 1 week | Safety of the neoLight device will be assessed as no change in an infant's temperature during phototherapy |
Countries
United States
Outcome results
None listed