Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial
NCT02929563 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116
Last updated 2020-09-02
Summary
This study tests the feasibility of a large study of stress ulcer prophylaxis in critically ill children. Children admitted to the Pediatric Intensive Care Unit who are expected to require mechanical ventilation for more than 48 hours will be randomized to intravenous pantoprazole 1 mg/kg or matching placebo once daily until they no longer need mechanical ventilation.
Conditions
- Gastrointestinal Hemorrhage
Interventions
- DRUG
-
Pantoprazole
- DRUG
-
Placebo (for pantoprazole)
Sponsors & Collaborators
-
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV - lead OTHER
Principal Investigators
-
Mark Duffett, PhD · McMaster University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 4 Months
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-09
- Primary Completion
- 2020-01-31
- Completion
- 2020-01-31
Countries
- Canada
Study Locations
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