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

NCT03723005 | Completed FDA Device

• 1 other identifier: IRB-41341
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperbilirubinemia, Neonatal

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Irradiance Stability of the neoLight Device

  1 year

• Infant Temperature Change

  up to 1 week

Study Arms (2)

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

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

Interventions

Neolight Phototherapy Mattress DEVICE

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.

Neolight Phototherapy Mattress

Standard-of-Care DEVICE

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

Eligibility Criteria

• Age: 28 Weeks - 8 Months
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Infant requiring respiratory assistance (such as mechanical ventilation)
• Severe or life-threatening congenital anomalies
• Blood transfusion history

Sponsors & Collaborators

• Stanford University: lead
• NeoLight, LLC.: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronald J Wong, MD

  Investigator

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 29, 2018
• Study Start: May 1, 2018
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: April 10, 2023

Record last verified: 2023-04

Locations

US (1)