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

Stanford University

Status: Completed

Conditions: Hyperbilirubinemia, Neonatal

Treatments: Device: Standard-of-Care; Device: Neolight Phototherapy Mattress

Study type: Observational

Funder types: Other

Identifiers

NCT03723005

IRB-41341

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 28 weeks to 8 months old

Volunteers: No Healthy Volunteers

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

Trial design

41 participants in 2 patient groups

Neolight Phototherapy Mattress

Description:

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.

Treatment:

Device: Neolight Phototherapy Mattress

Standard-of-Care Phototherapy

Description:

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.

Treatment:

Device: Standard-of-Care