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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

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.

Condition or disease Intervention/treatment
Hyperbilirubinemia, Neonatal 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Light Emitting Diode (LED) Mattress for Phototherapy of Jaundiced Newborns
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : September 4, 2019
Estimated Study Completion Date : September 4, 2019

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.




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   28 Weeks to 8 Months   (Child)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723005


Contacts
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Contact: David K Stevenson, MD 6507235711 dstevenson@stanford.edu
Contact: Cynthia Montiel, BS 6504987246 montielc@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: David K Stevenson, MD    650-723-4492    dks750@stanford.edu   
Contact: Cynthia Montiel, BS    6504987246    montielc@stanford.edu   
Sponsors and Collaborators
Stanford University
NeoLight, LLC.
Investigators
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Study Director: Ronald J Wong, MD Investigator

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Responsible Party: David K Stevenson, PI, Stanford University
ClinicalTrials.gov Identifier: NCT03723005     History of Changes
Other Study ID Numbers: IRB-41341
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (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.

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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

Additional relevant MeSH terms:
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Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Pathologic Processes
Infant, Newborn, Diseases