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

Hyperbilirubinemia, Neonatal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03723005
• Other study ID #: IRB-41341
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: April 4, 2023

Study information

• Verified date: April 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 4, 2023
• Est. primary completion date: April 4, 2023
• Gender: All
• Age group: 28 Weeks to 8 Months

Eligibility

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

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	NeoLight, LLC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Bilirubin (TB) Levels	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	up to 1 week
Primary	Duration of Phototherapy	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.	up to 1 week
Secondary	Irradiance Stability of the neoLight Device	The performance of the neoLight will be assessed as the stability of irradiance emitted by the neoLight device during the use of the device	1 year
Secondary	Infant Temperature Change	Safety of the neoLight device will be assessed as no change in an infant's temperature during phototherapy	up to 1 week