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

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ClinicalTrials.gov Identifier: NCT03723005
Recruitment Status : Recruiting
First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Collaborator:
NeoLight, LLC.
Information provided by (Responsible Party):
David K Stevenson, Stanford University

Tracking Information
First Submitted Date October 24, 2018
First Posted Date October 29, 2018
Last Update Posted Date October 29, 2018
Actual Study Start Date May 1, 2018
Estimated Primary Completion Date September 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 25, 2018)
  • Total Bilirubin (TB) Levels [ Time Frame: up 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 Phototherapy [ Time Frame: up 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 25, 2018)
  • Irradiance Stability of the neoLight Device [ Time Frame: 1 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 Change [ Time Frame: up to 1 week ]
    Safety of the neoLight device will be assessed as no change in an infant's temperature during phototherapy
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Light Emitting Diode (LED) Mattress for Phototherapy of Jaundiced Newborns
Official Title A Light Emitting Diode (LED) Mattress for Phototherapy of Jaundiced Newborns
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
  • 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.
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Device: Standard-of-Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 25, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 4, 2019
Estimated Primary Completion Date September 4, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 28 Weeks to 8 Months   (Child)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: David K Stevenson, MD 6507235711 dstevenson@stanford.edu
Contact: Cynthia Montiel, BS 6504987246 montielc@stanford.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03723005
Other Study ID Numbers IRB-41341
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Sharable statistical data in regards to efficacy of device compared to Standard-of-care devices already used in a hospital setting.
Responsible Party David K Stevenson, Stanford University
Study Sponsor Stanford University
Collaborators NeoLight, LLC.
Investigators
Study Director: Ronald J Wong, MD Investigator
PRS Account Stanford University
Verification Date October 2018