Brain cooling treatment for neonates with HIE has progressed to the point that major neonatal centers throughout the U.S. have developed specific policies and protocols for this treatment. In California, there are currently 14 hospitals that provide this treatment, all of which have Level III Neonatal Intensive Care Units.
Each of these hospitals have developed specific requirements and eligibility criteria for patients. Since many neonates who qualify for brain cooling are delivered at other hospitals and must be then transported to a hospital that offers brain cooling within 6 hours of birth, the eligibility criteria are basically clinical features that would lead to a diagnosis of hypoxic-ischemic encephalopathy.
Not surprisingly, these criteria are similar to the ACOG criteria for a diagnosis of perinatal asphyxia and include low Apgar scores, evidence of metabolic acidosis on a cord blood gas, and neonatal symptoms including early onset seizures.
The basic eligibility criteria includes evidence of an acute perinatal event, such as a placental abruption, cord prolapse, or severe fetal heart rate (FHR) abnormalities indicative of fetal distress; an Apgar score of less than five at 10 minutes of age; a pH on a cord or subsequent blood gas that is less than or equal to 7.0, or a base deficit of 16 mEq/L or greater; and continued need for ventilation.
Although the written protocols for brain cooling are very detailed with regard to both eligibility and the details of treatment, they are relatively devoid of any specifics about informed consent. Since brain cooling must begin within six hours of birth, and many infants require transfer from the birth hospital to another hospital with a brain cooling program, there is often little time to discuss the details of brain cooling with the parents.
Upon being offered the only treatment that offers the possibility of neurologic improvement, it is highly unlikely that any parent would refuse to consent to such treatment, but the written information given to parents is generally highly optimistic about the potential benefit of such treatment, and confirms that it is a safe procedure.
Although neither the American Academy of Pediatrics (AAP) nor the American College of Obstetricians and Gynecologists (ACOG) have yet recommended brain cooling as the standard of care for a child diagnosed with HIE at birth, this lack of recommendation is based on the fact that the studies conducted have only shown improvement at 18 months of age, and there are no studies on long term outcome.
However, in light of the studies that show no harm from this treatment, and the evidence of improved neurologic outcome at 18 months, the failure to offer such brain cooling treatment to a child who meets the eligibility criteria would certainly be a strong issue before any jury.
In situations where there is insufficient evidence of negligent care in the treatment of an acute cord prolapse or placental abruption, a failure to offer brain cooling to a child may be a sufficient basis for recovery in a medical malpractice action, without the need to prove that the initial HIE was preventable.
The studies that show a significant improvement in outcome, even at 18 months, should be sufficient to prove causation in a case where brain cooling was not offered for treatment after a clear diagnosis of HIE was established at birth.
**This is an excerpt from an article written by Dr. Bruce Fagel, which originally appeared in the January/February 2011 issue of the Consumer Attorneys of California's Forum Magazine.
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