NCT03723005

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 41 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 28 Weeks – 8 Months
• Healthy volunteers: —

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.

Conditions

• Hyperbilirubinemia, Neonatal

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	Standard-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.

Timeline

• Start date: 2018-05-01
• Primary completion: 2023-04-04
• Completion: 2023-04-04
• First posted: 2018-10-29
• Last updated: 2023-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study