About the Study
Therapeutic hypothermia (lowering the body temperature) has been successfully used in adults after cardiac arrest to improve survival and outcome. Hypothermia has also been studied in newborn infants who have suffered from perinatal asphyxia, but it has not been studied in infants or children who have had cardiac arrest.
When a person has a cardiac arrest, cells throughout body undergo severe stress which may result in cell injury or death. ...therapeutic hypothermia may prevent long term brain damage in patients who have had a cardiac arrest.
Brain cells are especially susceptible to lack of oxygen and blood supply that occur during a cardiac arrest. If enough cell injury occurs, long term brain damage and death may result.
Fever commonly occurs after cardiac arrest and is associated with worse outcome (death or brain damage). It is not known whether preventing elevated body temperature by keeping it in a normal range (Normothermia) or a below normal range (Hypothermia) results in less brain injury and greater survival.
In this study, children will be randomized, (like the flip of a coin), to receive:
- therapeutic hypothermia (lower the body temperature) or
- therapeutic normothermia (maintaining the normal body temperature).
About 900 children will be enrolled in this study over 6 years at approximately 37 clinical centers throughout the US and Canada. Enrollment in the THAPCA Trials began in September 2009 and enrollment ended February 2015.