Abstract
BackgroundDespite sparse pediatric data on effectiveness, the majority of critically ill children receive medications to prevent gastrointestinal (GI) bleeding. Stress ulcer prophylaxis may have unintended consequences—increasing the risk of nosocomial infections—which may be more serious and common than the bleeding which these drugs are prescribed to prevent. Randomized controlled trials (RCTs) in pediatric critical care are exceptionally challenging to complete, thus a rigorous pilot RCT is crucial. The objective of this pilot RCT is to assess the feasibility of a large multicentre RCT of stress ulcer prophylaxis with pantoprazole to prevent upper GI bleeding vs. placebo.MethodsA multi-centre blinded pilot RCT of 120 children in six Canadian PICUs. Children expected to require mechanical ventilation for more than 48 h will be randomized to receive intravenous pantoprazole 1 mg/kg or identical placebo once daily until they no longer need mechanical ventilation. We have four feasibility outcomes and will consider the trial successful if we achieve:Effective screening: If >80% of eligible patients are approached for consent.Timely enrollment: if >80% of participants receive their first dose of the assigned study drug within 1 day of becoming eligible.Participant accrual: If the average monthly enrolment is two or more participants per centre per month.Protocol adherence: if >90% of doses are administered according to the protocol.DiscussionThere are many uncertainties about the risks and benefits of stress ulcer prophylaxis. In an era of widespread use—where clinicians prescribe prophylaxis to the more severely ill—a large, rigorous RCT is required. A trial to determine if a strategy of withholding stress ulcer prophylaxis is not inferior to a strategy of routine stress ulcer prophylaxis will be challenging. A carefully designed and implemented pilot trial is essential.Trial registrationClinicalTrials.gov:NCT02929563 (Registered October 3, 2016).
Highlights
Despite sparse pediatric data on effectiveness, the majority of critically ill children receive medications to prevent gastrointestinal (GI) bleeding
Factors we considered in estimating the sample size were threefold: 2. Number of centres: To ensure that the results are generalizable beyond a few highly-motivated centres and to reflect the centres that will enroll children in the large trial, six pediatric intensive care unit (PICU) will recruit participants
Large Randomized controlled trial (RCT) are uncommon in pediatric critical care; only 10 trials randomizing more than 500 children have been published [13]
Summary
Despite sparse pediatric data on effectiveness, the majority of critically ill children receive medications to prevent gastrointestinal (GI) bleeding. Randomized controlled trials (RCTs) in pediatric critical care are exceptionally challenging to complete, a rigorous pilot RCT is crucial. The objective of this pilot RCT is to assess the feasibility of a large multicentre RCT of stress ulcer prophylaxis with pantoprazole to prevent upper GI bleeding vs placebo. In observational studies the incidence of important bleeding ranged from 0.4 to 5% [1,2,3,4,5] This bleeding is associated with more red blood cell transfusions, longer duration of mechanical ventilation and stay in the pediatric intensive care unit (PICU) as well as increased healthcare costs [6]. In a prospective observational study of 398 children from five PICUs in Brazil, 78% of children received prophylaxis [7]
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