Observational study on cooling treatment for reducing epilepsy in newborns: what’s new?

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The release doesn’t address cost. Given that the cost can run into thousands of dollars, that’s a significant issue.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The headline claims a reduction in epilepsy but the release does not provide any numbers backing up that claim. The closest the release comes to describing a benefit is stating that the children “had much less epilepsy than before cooling treatment was introduced.” How much less?

The release would have been somewhat stronger if it had offered some firm numbers for this group of patients given the lack of a control group.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

Therapeutic hypothermia is widely regarded as safe, if the treatment is provided by practitioners with the right expertise to patients who meet the relevant criteria.

Forcing the human body to the wrong temperature can cause many potentially serious side effects, including bleeding, infection, dehydration and low magnesium. It is relatively safe only because of expert management by ICU personnel familiar with the procedure.

All of that needs to be mentioned, whereas the release doesn’t address the risks.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

As we’ve pointed out above, this is an observational study. But the headline claim is “Cooling treatment reduces epilepsy in children.” That’s a cause and effect claim, and an overstatement of what this study could measure. Observational studies do not prove cause and effect.

The release points out that in babies born after 2007, 7 percent had an epilepsy diagnosis, however, far fewer, only 2 per cent, were on regular antiepileptic drugs. But other advancements in caring for infants in neonatal ICUs (along with cooling treatments) could account for reduced epilepsy rates compared with historical controls. That’s a consideration that could have been noted in the release.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

Someone reading the release could easily think that therapeutic hypothermia is a treatment currently available only from the researchers who worked on this study. That’s not the case. It’s not something available at every hospital, but it is available at many hospitals. A 2014 report from the American Academy of Pediatrics addressed related limitations and challenges regarding the use of hypothermia to treat neonatal encephalopathy. This quote from that report would seem to apply here as well: “Infants selected for cooling must meet the criteria outlined in published clinical trials. The implementation of cooling needs to be performed at centers that have the capability to manage medically complex infants. Because the majority of infants who have neonatal encephalopathy are born at community hospitals, centers that perform cooling should work with their referring hospitals to implement education programs focused on increasing the awareness and identification of infants at risk for encephalopathy, and the initial clinical management of affected infants.”

Does the news release establish the true novelty of the approach?

Not Satisfactory

The novelty here would appear to be that this is the first study to look specifically at the extent to which therapeutic hypothermia reduces the rates and severity of epilepsy in children who suffered from perinatal asphyxia as newborns. However, the release doesn’t tell us that. Nor does it do anything to let readers know that this subject has been the focal point of at least half a dozen large, randomized, clinical trials. To be clear, this new journal article may offer important new information to researchers, clinicians and parents — but the release needs to do a better job of articulating what is new and how this work builds on (or differs from) previous work.