Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial

Despite sparse pediatric data on the effectiveness of stress ulcer prophylaxis to prevent gastrointestinal (GI) bleeding, 60% of critically ill children receive these medications. This may have unintended consequences - increasing the risk of nosocomial infections - which may be more serious and common than bleeding these drugs are prescribed to prevent. A large randomized trial (RCT) is needed to assess the balance of these risks and benefits, to determine if a strategy of withholding stress ulcer prophylaxis in critically ill children is not inferior to a strategy of routine stress ulcer prophylaxis. RCTs in pediatric critical care are exceptionally challenging to complete; thus, a rigorous pilot RCT is crucial. The pilot may prevent pursuit of a trial that is ultimately not feasible - which is ethically and financially responsible. It is more likely that this carefully designed pilot trial will ensure that the larger trial we undertake is successful.

Inclusion criteria

• less than 18 years of age
• >4 months of age
• requires respiratory support in the form of invasive mechanical ventilation, non-invasive mechanical ventilation, or high-flow oxygen
• the attending physician expects the child to require respiratory support for at least 2 more days

Exclusion criteria

• histamine-2 receptor antagonist (H2RA) or proton pump inhibitor (PPI) use for >1 week in the past month
• active GI bleeding Blood in the nasogastric (NG) tube or coffee-ground emesis suspected by the attending physician to be from the oropharynx is not an exclusion criterion.
• documented severe reflux, active H. pylori infection, severe esophagitis, Zollinger Ellison syndrome, Barrett's esophagus, peptic ulcer bleeding within 8 weeks
• are receiving methylprednisolone 15 mg/kg/day or more (or equivalent) Equivalent doses: methylprednisolone, prednisone or prednisolone 15 mg/kg/day; dexamethasone 3 mg/kg/day; hydrocortisone 60 mg/kg/day
• are receiving mycophenolate (enteral), methotrexate, nelfinavir, atazanavir, saquinavir, posaconazole
• chronic ventilation on usual pressure settings and rate
• nocturnal or intermittent non-invasive ventilation only
• are eating, nursing, or if chronically fed via feeding tube, receiving usual feeds
• received more than 1 daily-dose equivalent of acid suppressive medication in the PICU
• were previously enrolled in this trial
• are currently enrolled in a potentially confounding trial
• are known to be pregnant or breastfeeding
• are known to be allergic to pantoprazole or any other ingredient in the product
• are not expected to survive this PICU admission because of palliative care or limited life support