Anticonvulsants for Neonatal Seizures

FOR THE TREATMENT OF NEONATAL SEIZURES

Treatment
Treatment
  • PREVENTION
  • DIAGNOSTIC
  • TREATMENT
  • OVERVIEW
  • TECHNOLOGY Characteristics
  • Anticonvulsants for Neonatal Seizures
    Phenobarbital sodium for injection

    Global annual deaths associated with neonatal seizures

    PERCENT (%)
    NUMBER

    Maternal

    N/A
    N/A

    Neonatal

    *
    *

    Stillbirth

    N/A
    N/A
    *Estimates under development

    Condition
    Neonatal seizures are relatively common, occurring in 0.07-.27% of live term births and 5.8-13.2% of live premature births. Neonatal seizures can be difficult to diagnose, especially without EEG, as they are not typically generalized tonic-clonic events. In addition, not all seizures require treatment. When an anticonvulsant is indicated, phenobarbital is the most commonly administered drug followed by phenytoin.


    Mechanism of Action
    Phenobarbital is often used in concert with another nonbenzodiazepine antiepileptic drug (NBAED) such as phenytoin. Benzodiazepines such as midazolam, lorazepam, or diazepam are more rarely used. Diazepam's long half-life in babies makes it unsuitable for use in prolonged infusions. Studies have shown that phenobarbital is effective in controlling seizures in less than 50% in infants; when used in concert with phenytoin, this number rises to about two thirds. Phenobarbital depresses the nervous system and is a sedative at high doses; neonates may require respiratory assistance during treatment.

    Current Use in High-Resource Settings
    While phenobarbital is the preferred first-line treatment for neonatal seizures, there is considerable controversy as to whether seizures are enough of a health risk to the neonate to warrant the use of anticonvulsants. There are no large-scale studies comparing the effectiveness of antiepileptic drugs against a placebo. When used, therapeutic serum concentrations of phenobarbital are typically 20-40 mg/l. This can be achieved using a loading dose of 40 mg/kg for infants on ventilation, or split between two doses of 20 mg/kg for infants without ventilators. A 10-15 minute infusion IV is most common, but IM and oral dosing is possible. Phenytoin is administered as a 15 mg/kg IV 'push' at a rate no greater than 1 mg/kg per min. Oral dosing is possible as well.

    Application in Low-Resource Settings
    Neonatal seizures are particularly common in low-resource nations, possibly due to higher rates of infection, asphyxia, meningitis, and stroke. The incidence of seizures may be higher in developing locations with higher rates of infants resuscitated due to birth asphyxia. The treatment of choice is still phenobarbital, due to its availability and low cost.

    REPRESENTATIVE DEVICES

    DRUG
    FORMAT
    PRICE
    STATUS
    NOTES

    Phenobarbital

    100mg/mL Injection
    $0.32
    Marketed
    Typically preferred NICU route

    Phenobarbital

    100mg Tablet
    $0.005
    Marketed
    Can be prescribed for home use

    Phenytoin

    100mg Tablet
    $0.01
    Marketed
    Metabolism can be unpredictable

  • CHARACTERISTICS OF REPRESENTATIVE PRODUCT

    TECHNOLOGY CHARACTERISTICS

    OPERATIONAL PARAMETERS

    POTENTIAL OPPORTUNITIES FOR IMPROVEMENT

    SKILLS

    REQUIRED

    Intended end user
    Training required
    Time required per use
    Nurse, doctor
    Hours
    10-15 mins

    The skills required to administer phenobarbital may be more common than the ability to correctly diagnose neonatal seizures. The drug is often overprescribed.

    ENVIRONMENT/ INFRASTRUCTURE

    Power required
    Waste collection
    Complementary technologies required
    Temperature and storage
    Maintenance
    None
    None
    An infusion pump eases administration but is not strictly required
    4-5 year shelf life when stored <30°C
    None

    While oral phenobarbital is available, it may be helpful primarily to buy time in a home setting. A skilled provider must be present for its use at home. Neonates on phenobarbital are likely to need facility-based care for concurrent afflictions, and the IV route is most commonly recommended.

    COST

    Device Cost (Approx)
    Cost/course (Approx)
    $0.32
    $0.32

    OTHER

    Portability
    Regulatory
    Efficacy
    <100g
    Approximately 50% when used alone

    Additional devices required for impact: Neonates on phenobarbital often have several concurrent afflictions requiring facility-based medical attention

Sources: Blume HK, Garrison MM, Christakis DA. Neonatal seizures: treatment and treatment variability in 31 US pediatric hospitals. J Child Neurol. 2009;24:148-154. Booth D, Evans DJ. Anticonvulsants for neonates with seizures. Cochrane Database of Systematic Reviews 2004, Issue 3. Art. No.: CD004218. DOI: 10.1002/14651858.CD004218.pub2. Mwaniki M, Mathenge A, Gwer S, Mturi N, Bauni E, Newton CRJC, Berkley J, Idro R. Neonatal seizures in a rural Kenyan District Hospital: aetiology, Incidence and outcome of hospitalization. BMC Medicine 2010; 8(6). Rennie JM, Boylan GB. Neonatal seizures and their treatment. Current Opinion in Neurology 2003; 16(2):177-81. http://onlinelibrary.wiley.com.proxy.lib.duke.edu/doi/10.1002/14651858.CD004218.pub2/abstract Booth D, Evans DJ. Anticonvulsants for neonates with seizures. Cochrane Database of Systematic Reviews 2004, Issue 3. Art. No.: CD004218. DOI: 10.1002/14651858.CD004218.pub2.