Corticosteroids

to reduce the incidence of respiratory distress

Prevention
Prevention
  • PREVENTION
  • DIAGNOSTIC
  • TREATMENT
  • OVERVIEW
  • TECHNOLOGY Characteristics
  • Corticosteroids
    Representative Product

    GLOBAL ANNUAL DEATHS ASSOCIATED WITH NEONATAL RESPIRATORY DISTRESS

    PERCENT (%)
    NUMBER

    Maternal

    N/A
    N/A

    Neonatal

    20-25%
    765,000

    Stillbirth

    N/A
    N/A

    Condition

    Infant respiratory distress syndrome (RDS) occurs in 40-50% of neonates born prior to 32 weeks. RDS is caused by structural immaturity of the lungs and insufficient surfactant production. Corticosteroids can accelerate lung maturation, decreasing the severity or preventing RDS. Corticosteroids (more specifically glucocorticoids) are frequently given antenatally to women at risk of preterm delivery. This often reduces the treatment the preterm infant will require to survive at birth.


    Mechanism of Action
    Corticosteroids (specifically betamethasone or dexamethasone) administered to a gravid woman cross the placenta to promote accelerated fetal lung maturation and production of surfactant. Corticosteroids may be administered intramuscularly at 28-36 weeks of gestation in gravid women who show signs they may deliver preterm. In order for this treatment to be most effective, delivery should not occur for 24-48 hours after the drug is administered. Betamethasone has been used for decades and is the preferred corticosteroid for this function. Two doses of 12mg are recommended intramuscularly, 24 hours apart.
     

    Current use in High-Resource Settings
    Corticosteroids are not currently labeled for use in preterm labor in the US; however, coricosteroids are commonly used for preterm delivery. Given the relatively low cost and ease of administration, increased penetration is limited by the ability to quickly diagnose an at-risk fetus. Cost savings associated with the avoidance of surfactant and respiratory support are substantial.

    Application in Low-Resource Settings
    Where surfactant and ventilation are less likely to be available, corticosteroid use has the potential to save lives. In facility settings and among skilled attendants, intramuscular injection is feasible. There are ongoing efforts to pre-load betamethasone into the Uniject device in order to further reduce the skill required for administration. This could expand the base of end users, but is not yet commercially available. Corticosteroid therapy is not advised for women who have systemic infections such as tuberculosis. Caregivers in regions with high prevalence of infectious disease must be more cautious before administration of this drug.

     

    REPRESENTATIVE DEVICES

    MAKE
    MODEL
    PRICE*
    TECH
    STATUS
    NOTES

    Schering-Plough

    Celestone Soluspan
    $50
    2, 12 mg injections
    Marketed
    Branded product at premium

    Generic

    Dexamethasone
    $12
    2, 6 mg injections
    Marketed
    Generics widely available

    * 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
    Hours
    Minutes

    Correct and timely diagnosis is a major barrier where gestational age is unknown. The availability of trained staff is crucial to effective administration.

    ENVIRONMENT/ INFRASTRUCTURE

    Power required
    Waste collection
    Complementary technologies required
    Temperature and storage
    Maintenance
    None
    Sharps
    Syringe (or Uniject)
    Store vial at 25ºC; excursions permitted15-30ºC. Protect from light.
    None

    Timing is a critical factor, since the largest benefit occurs with administration 24-48 hours prior to delivery.

    COST

    Device Cost (Approx)
    Cost/course (Approx)
    $1-$35
    $1-$35

    OTHER

    Portability
    Regulatory
    Efficacy
    <10g
    Uniject not yet approved
    Unknown for environments where advanced neonatal care is unavailable.

    Additional devices and procedures required for impact: A way to identify women in preterm labor (e.g. a method to measure fundal height and a gestational age wheel); a sufficient infrastructure to support common complications of pre-term infants, a way to prolong labor such as the drug ritodrine.

Sources: Food and Drug Administration. (1998). Food and Drug Administration Center for Drug Evaluation and Research Advisory Committee for Reproductive Health Drugs.Gaithersburg: Freilicher & Associates, Court Reporters. Hofmeyr GJ. Antenatal corticosteroids for women at risk of preterm birth: RHL commentary (last revised: 2 February 2009). The WHO Reproductive Health Library; Geneva: World Health Organization. Merck. (2009, February). The Merck Manuals: Online Medical Library. Retrieved June 15, 2010, from Respiratory Distress Syndrome: http://www.merck.com/mmhe/sec23/ch264/ch264g.html. Merck. (2010, January). The Merck Manuals: Online Medical Library. Retrieved June 16, 2010 Royal College of Obstetricians and Gynaecologists. (2004). Antenatal Corticosteroids to Prevent Respiratory Distress Syndrome.Toronto: Guidelines and Audit Committee of the RCOG . Schering-Plough. (2009). Celestone® Soluspan® Product Information.Kenilworth: Schering Corporation. UCB Pharma Ltd. (2009). Patient Information Leaflet: Betnesol 4 mg/mL Injection Betamethasone Sodium Phosphate.Berkshire: UCB Pharma Ltd http://www.who.int/reproductivehealth/topics/best_practices/greatproject_implementation/en/index.html Brownfoot, F. C., C. A. Crowther, et al. (2008). "Different corticosteroids and regimens for accelerating fetal lung maturation for women at risk of preterm birth." Cochrane Database Syst Rev 4. Roberts, D. and S. Dalziel (2006). "Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth." Cochrane Database Syst Rev 3(3). UN Commission/Born Too soon Care Antenatal Corticosteroids Working Group. (2013). Dexamethasone versus betamethasone as an antenatal corticosteroid.