Reducing morbidity in critically ill children by re-evaluating the prophylaxis of stress ulcer-related upper gastrointestinal bleeding: A pilot randomized controlled trial.

All critically ill children receive medications when they are in the Pediatric Intensive Care Unit (PICU). Reducing the side effects from these medications is an urgent research priority. One common reason critically ill children are given medications is to prevent ulcers in their stomachs. These can be caused by the strong stress to the body from acute and severe illness. These ulcers can cause severe stomach bleeding. Therefore, preventing stress ulcers with medications that decrease stomach acid is part of daily practice in the PICU. We know from other groups of patients that these medications have side effects. They increase the risk of pneumonia and the risk of infection with Clostridium difficile (diarrhea, fever, cramping, pain, and severe disease may need surgery). Both of these infections can have important consequences. Children who develop these infections need life support for longer, more time in the PICU, and treatment with more antibiotics. Despite little testing in children, more than 60% of critically ill children receive these medications to prevent stress ulcers and bleeding. Because so little testing has been done in critically ill children, we do not know if the benefits of these medications (reduced bleeding) outweigh the risk of side effects (increased infections). A large study is needed to test whether not giving these medications reduces bleeding without increasing the risk of side effects. Such studies in children are very challenging to do but very important. These medications are used in most critically ill children worldwide. To see if doing large study is feasible, we will first do a smaller study of 120 children in 6 PICUs. The goal of the small study will be to test if we can enroll enough children and test our study protocol, staff and procedures. If we can meet our targets in the small study, we can be confident that we can successfully complete a large study testing the effect of giving medicines to prevent stress ulcers.