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OpenTrials
Completed

NCT Number: NCT03723005

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.

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Key information

Conditions

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

Age range

28 week–8 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University

Palo Alto, California, 94305, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • NeoLight, LLC.

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 29, 2018
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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