Results from a large multi center trial recently showed that emergency body hypothermia did not offer a significant benefit in survival with a good functional outcome at 1 year or reduce brain injury in infants and children with out-of-hospital cardiac arrest more than normal temperature control. The study findings are published in the New England Journal of Medicine and were presented during the Annual Meeting of the Pediatric Academic Societies in San Diego.
Therapeutic hypothermia is recommended for comatose adults after witnessed out-of-hospital cardiac arrest and also for newborns with brain injury due to a lack of oxygen at birth, but data about this intervention in children admitted to hospitals with cardiac arrest remains limited.
“Our results show that therapeutic hypothermia is no more effective for treating children after out-of-hospital cardiac arrest than maintaining body temperature within the normal range, ” said in a news release co-principal investigator Frank W. Moler, M.D., a professor in the Department of Pediatrics and Communicable Diseases at the University of Michigan, Ann Arbor. “Both treatments help to control fever and result in similar outcomes for patients.”
In the U.S each year, more than 6,000 children suffer out-of-hospital cardiac arrest, a situation where the heart stops pumping effectively, and blood stops flowing to the brain and other vital organs. The outcome of cardiac arrest is death or long-term disability in the majority of the cases.
The research included a total of 295 patients aged between 2 days and 18 years admitted to children’s hospitals for cardiac arrest, needing chest compressions for at least two minutes and dependent on mechanical ventilation to breathe. Children underwent randomization to one of two treatment groups: One group received body cooling for two days followed by three days of normal temperature control and the other group received normal temperature control for five days.
Among the 260 patients with data that could be could be evaluated and who had a VABS-II score of at least 70 before cardiac arrest, there was no significant difference in the primary outcome between the hypothermia group and the normothermia group (20% vs. 12%).
Among all the patients with data that could be evaluated, the change in the VABS-II score from baseline to 12 months was not significantly different and 1-year survival was similar (38% in the hypothermia group vs. 29% in the normothermia group).
The researchers are also working on a project examining hypothermia in hospitalized patients who suffer cardiac arrest, typically as a complication of a medical condition. A goal of both studies is preventing fever, which commonly occurs after cardiac arrest and can lead to more severe outcomes.
“The findings from these studies may well lead to evidence-based guidelines that will improve the quality and rates of pediatric cardiac arrest survival by using better treatments,” said co-principal investigator J. Michael Dean, M.D., professor of pediatrics and chief of the Division of Pediatric Critical Care Medicine at the University of Utah School of Medicine, Salt Lake City. “Our hope is to identify the most effective treatment for preventing neurological damage or death in infants and children who suffer cardiac arrest.”
Both studies are patients of the Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA) trials, a six-year effort that is the largest examination of therapeutic hypothermia in children other than newborns for any health condition to date. The trials are funded through NHLBI cooperative agreements U01-HL-094339 and U01-HL-094345.
“Partnerships with these federally funded pediatric clinical research networks have been essential to the trials,” said Victoria Pemberton, R.N.C., clinical trials specialist and THAPCA project scientist at NHLBI. “Through the networks, we have been able to mobilize researchers and clinicians throughout North America to answer important questions about a population with a rare health condition.”