Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

This study is looking for children aged from 2 days old up to 17 years old who have had a heart attack outside of hospital and are still unconscious. To be considered, the child must have needed chest compressions for at least two minutes and begun cooling treatment to control their temperature. They also need to be on a breathing machine and have started the study assessment within six hours of their heart starting to beat normally again. A parent or legal guardian will need to give permission, and they must agree to continue life support for at least 120 hours (5 days) as part of the study.

However, some things would mean a child cannot take part. For example, if they were unconscious but could move all their limbs on command *before* they joined the study, or if their legal guardian doesn't speak English or Spanish. Children who needed CPR for more than 60 minutes, or who have very unstable blood pressure requiring strong medications or a special machine called ECMO, would not be eligible. Also, children with certain existing serious health problems, like severe brain development issues, a terminal illness, or specific blood disorders like sickle cell anemia, cannot participate. The study also cannot include children whose heart attack was due to a severe injury to their brain, chest, or tummy, or those with severe bleeding or extensive burns.

If your child is eligible for the P-ICECAP study, they will receive the standard cooling treatment that doctors already use after a heart attack. The main difference is that they will be randomly assigned to either receive the usual duration of cooling or a slightly longer duration. This is done by chance, like flipping a coin, so it's fair. The medical team will carefully monitor your child's temperature and overall health throughout this period. There are no additional medications given specifically for the study outside of what a child would normally receive in their critical care journey.

Doctors and nurses will be closely watching your child's progress, especially their brain recovery, after the cooling treatment. While there aren't extra 'visits' in the traditional sense, as your child will be in the hospital's intensive care unit, the study involves collecting information from their medical records about their recovery. The total duration of the active study intervention (the cooling period) is relatively short, but the team will follow up on your child's development for a longer period to understand the long-term effects of the different cooling durations. The specifics of follow-up will be explained by the study team, but it wouldn’t involve additional hospital stays.