Palo Alto, California 94305


Purpose:

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.


Study 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. 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.


Criteria:

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


NCT ID:

NCT03723005


Primary Contact:

Study Director
Ronald J Wong, MD
Investigator

David K Stevenson, MD
Phone: 6507235711
Email: dstevenson@stanford.edu


Backup Contact:

Email: montielc@stanford.edu
Cynthia Montiel, BS
Phone: 6504987246


Location Contact:

Palo Alto, California 94305
United States

David K Stevenson, MD
Phone: 650-723-4492
Email: dks750@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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