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

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 Overview

• Status: Completed
• Conditions: Hyperbilirubinemia, Neonatal
• Intervention / Treatment: Device: Neolight Phototherapy Mattress; Device: Standard-of-Care

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.

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

• Study Contact: Name: David K Stevenson, MD; Phone Number: 6507235711; Email: dstevenson@stanford.edu
• Study Contact Backup: Name: Cynthia Montiel, BS; Phone Number: 6504987246; Email: montielc@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 8 months (Child)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All infants (not gender or racial/ethnically based) equal or greater than 28 weeks GA and great than 6 hrs of age until hospital discharge.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: 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 Phototherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: NeoLight, LLC.
• Investigators: Study Director: Ronald J Wong, MD, Investigator

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): April 4, 2023
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal
• Other Study ID Numbers: IRB-41341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Sharable statistical data in regards to efficacy of device compared to Standard-of-care devices already used in a hospital setting.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No