Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns
Condition: Jaundice, Neonatal; Neonatal Hyperbilirubinemia; Neonatal Disorder
MeSH terms: Hyperbilirubinemia, Neonatal; Jaundice, Neonatal; Infant, Newborn, Diseases; Jaundice; Hyperbilirubinemia
Study type: Interventional

Summary: 
      Phototherapy has served as a primary treatment for hyperbilirubinemia in newborn populations.
      The light emitted through phototherapy interacts with bilirubin at the skin level to
      transform it into water-soluble products eliminated in urine and stool. Efficacy of
      phototherapy relies on the irradiance dispensed at the skin level by the treatment and on the
      surface area of skin exposed. The purpose of this Investigator-initiated, prospective,
      two-arm, randomized control investigation is to compare the effect of a novel, newly
      available, FDA cleared, phototherapy device (Neolight Skylife) with the standard phototherapy
      treatments used in HonorHealth newborn nurseries (Natus-Neo Blue Blanket and GE Bili Soft
      Blanket) on healthy, newborns ≥ 35 weeks + 0 days Gestational Age (GA) at the time of birth
      in the treatment of hyperbilirubinemia. We hypothesize that the unconjugated bilirubin level
      will be comparably reduced across each treatment arm from baseline to 12 and 24 hour
      intervals.
    

Detailed description: 
      This is an investigator-initiated, prospective, two-arm randomized control investigation to
      examine the mean values in patients' unconjugated bilirubin level for a new, FDA cleared
      device (Neolight Skylife) with the standard phototherapy treatment. Patient data on
      unconjugated bilirubin level, pressure ulcer and body temperature will be evaluated at
      baseline, 12-hours post-intervention, 24 hours post-intervention and at discharge.

      Neolight Skylife is a compact device that offers phototherapy to infants across all neonatal
      beds, supplanting multiple, enclosure specific phototherapy devices. Neolight Skylife weighs
      less than 10 lbs. and is ergonomically designed for portability that allows for easy carrying
      of the device between beds. Neolight Skylife offers the choice between treatment intensity
      levels. Neolight Skylife utilizes blue Light-Emitting Diodes (LEDs) to achieve low irradiance
      of 30 plus or minus 5 μw/cm²/nm, and high irradiance of 45 plus or minus 10, μw/cm²/nm.
      Neolight Skylife emits light in a narrow bandwidth between 430-475 nm. This light bandwidth
      corresponds to the spectral absorption of light by bilirubin, and is thus considered to be
      the most effective for treatment. Neolight Skylife eliminates the risk of UV exposure
      typically seen with phototherapy treatment through the use of blue LEDs, as this light source
      does not emit significant energy in the ultraviolet (UV) spectrum. However, as with all
      phototherapy treatment, protective eye coverings are used to protect the baby's eyes from
      excessive light exposure.
    

Intervention name(s): Skylife; Standard Therapy
Intervention type(s): Device; Device
Intervention description(s): Newly FDA approved device; Both devices are considered standard therapy
Other intervention name(s): Natus-Neo Blue Blanket; GE Bili Soft Blanket
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research