MedPath

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

Completed
Conditions
Hyperbilirubinemia, Neonatal
Interventions
Device: Neolight Phototherapy Mattress
Device: Standard-of-Care
Registration Number
NCT03723005
Lead Sponsor
Stanford University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
41
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
Read More
Exclusion Criteria
  • Infant requiring respiratory assistance (such as mechanical ventilation)
  • Severe or life-threatening congenital anomalies
  • Blood transfusion history
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Neolight Phototherapy MattressNeolight Phototherapy MattressOnce 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 PhototherapyStandard-of-CareOnce 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.
Primary Outcome Measures
NameTimeMethod
Total Bilirubin (TB) Levelsup 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 Phototherapyup 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 Outcome Measures
NameTimeMethod
Irradiance Stability of the neoLight Device1 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 Changeup to 1 week

Safety of the neoLight device will be assessed as no change in an infant's temperature during phototherapy

Trial Locations

Locations (1)

Stanford University

🇺🇸

Palo Alto, California, United States

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