Phototherapy

FOR THE TREATMENT OF NEONATAL JAUNDICE

Prevention/Treatment
Prevention/Treatment
  • PREVENTION
  • DIAGNOSTIC
  • TREATMENT
  • OVERVIEW
  • TECHNOLOGY Characteristics
  • Phototherapy
    Representative Product

    Condition
    Neonatal hyperbilirubinemia (usually seen as jaundice) is a usually mild condition in newborns affecting up to 50% of neonates. Elevated bilirubin levels cause the skin and other tissues to look yellowish on inspection. Furthermore, high levels of bilirubin can cause bilirubin toxicity, then acute bilirubin encephalopathy and ultimately kernicterus--irreparable brain damage. Acute bilirubin encephalopathy and kernicterus are characterized by athetoid cerebral palsy--leading to involuntary, purposeless movements-- as well as auditory dysfunction, dental problems, and mental handicaps.

    Mechanism of Action
    Phototherapy lowers the concentration of bilirubin by enabling it to be more easily excreted. Blue light (430 to 490nm) matches the absorption spectrum of bilirubin and drives a photoreaction, transforming bilirubin into water-soluble products which can be excreted in urine and bile. A baby is typically exposed continuously over the course of one or more days. Efficacy depends on irradiance (light intensity); the American Academy of Pediatrics (AAP) intensive phototherapy standard is 30 μW/cm2/nm. Any light source that can provide the required color and power can be used, even filtered sunlight.

    Current Use in High-Resource Settings
    LED-based systems have become increasingly popular in high-resource settings for their intensive irradiance and low maintenance requirements. If phototherapy fails, exchange blood transfusions are used as a last resort. In the US fewer than 1% of neonatal hyperbilirubinemia patients require more than phototherapy.

    Application in Low-Resource Settings
    In resource limited settings, fluorescent devices are commonly used and are often locally produced. However, the commonly used fluorescent bulbs need frequent replacement. In practice such devices often have burnt out bulbs, or have bulbs that have been replaced with low irradiance white light which will only function at a fraction the prescribed effectiveness. Low cost LED units offer 10 year bulb lives while meeting the AAP intensive phototherapy standards. More radically, ultra low cost treatments under development include blue filters for use under direct sunlight.

    REPRESENTATIVE DEVICES

    MAKE
    MODEL
    PRICE*
    TECH
    STATUS
    NOTES

    Natus

    neoBLUE
    $3,500
    LED
    Marketed
    Standard of care in US

    Olympic

    Bili-Lite
    $2,300
    Fluorescent
    Marketed
    American made tube light

    GE

    BiliSoft
    $>2,000
    LED+Fiber
    Marketed
    Flexible “blanket” illuminates baby

    D-Rev

    Brilliance
    $400
    LED
    Marketed
    Sold in India via Phoenix Medical

    DtM

    Firefly
    $350
    Blue light
    Marketed
    Field testing in Vietnam

    Phoenix

    CFL-101
    $300
    Fluorescent
    Marketed
    Array of 6 CFL bulbs

    Delta

    TL
    $200
    Fluorescent
    Marketed
    Lowest cost Indian option

    * Prices are approximated. Actual pricing can, and will vary by marketplace and market conditions.

  • CHARACTERISTICS OF REPRESENTATIVE PRODUCT

    TECHNOLOGY CHARACTERISTICS

    OPERATIONAL PARAMETERS

    POTENTIAL OPPORTUNITIES FOR IMPROVEMENT

    SKILLS

    REQUIRED

    Intended end user
    Training required
    Time required per use
    Physician, nurse/midwife
    Hours
    1-3 days

    A simple mechanism to indicate proper distance between a phototherapy device and baby would facilitate effective treatment by low skill level medical workers. However, these distance-indicating mechanisms are occasionally misplaced. Errors in placement can under or overdose the neonate.

    ENVIRONMENT/ INFRASTRUCTURE

    Power required
    Waste collection
    Complementary technologies required
    Temperature and storage
    Maintenance
    30 W
    None
    Eye & gonad covers, bassinet and warmer
    0 to 40°C
    Bulb life of 10 yrs

    Reduction in power requirement would enable low-cost battery backup. This would facilitate phototherapy treatment in clinics with intermittent electrical power.

    COST

    Device Cost (Approx)
    Cost/course (Approx)
    $400
    Variable depending on local cost of power, <$1

    Further development in high efficiency LED technology could significantly reduce the device cost, as LEDs are the greatest component cost.

    OTHER

    Portability
    Regulatory
    Efficacy
    <500g
    Irradiance meets 2004 AAP intensive phototherapy standard

    Additional devices required for impact: hyperbilirubinemia diagnostic and eye and gonad covers

Sources: Maisels MJ, McDonagh AF. Phototherapy for neonatal jaundice. N Engl J Med. 2008;358:920 –928. American Academy of Pediatrics. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics 2004; 114: 297-316. Burke BL, Robbins JM, Bird TM, Hobbs CA, Nesmith C, Tilford JM. Trends of hospitalizations for neonatal jaundice and kernicterus in United States, 1988–2005. Pediatrics 2009; 123: 524–32.