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

Reducing the adverse effects experienced by critically ill children is an urgent research priority. Acute and severe illness can cause stress ulcers in the stomach. These ulcers can cause severe bleeding. Thus it makes sense trying to prevent stress ulcers, which can be done with drugs that decrease stomach acid. Despite little testing in children, more than half of critically ill children receive these medications. These may increase the risk of infections, which may be more common than bleeding itself. A large study is needed to test if withholding these medications reduces the risk of side effects and adverse events without increasing the risk of bleeding. Such trials in pediatric critical care are exceptionally challenging to complete. We are conducting a pilot randomized controlled trial in 6 Canadian Pediatric Intensive Care Units (PICUs) to test and refine the study procedures and see if a large trial is feasible to do. Children receiving life support in a PICU can participate. They will be given either a commonly used medication (pantoprazole) to reduce their stomach acid levels or an inactive placebo while they are in the PICU. We measure important aspects of successfully completing a trial: how many children we can recruit at each PICU, how quickly we can start the study medication, adherence to study protocol, and how often the study medication is given according to our protocol. This pilot trial is a critical part of a research program needed to ensure that a large trial is successful. The large trial will tell us if giving prophylaxis or withholding it is the preferred strategy. Either outcome will allow clinicians to reduce the burden of morbidity in all mechanically ventilated children balancing the risks and benefits of prophylaxis. This pilot trial will be critical to successfully completing such a challenging trial.