Stress Ulcer Prophylaxis Versus Placebo in Critically Ill Infants With Congenital Heart Disease
Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
Summary
Infants with congenital heart disease often require an intervention during their first year
of life. Infants are generally admitted to a cardiac intensive care unit and are routinely
prescribed stress ulcer prophylaxis to decrease acid release from the stomach to prevent
stress ulcer formation. However, these medicines may not be safe and could put infants at
increased risk for hospital-acquired infections, necrotizing enterocolitis and alteration to
the infant's microbiome. The investigators plan to assess the feasibility of conducting a
prospective, blinded randomized control trial to determine the safety of withholding stress
ulcer prophylaxis in critically ill infants with congenital heart disease. In addition, the
investigators plan to examine the changes to the infant's microbiome through oral, gastric
and stool samples and compare hospital-acquired infections.
Phase:
Phase 4
Details
Lead Sponsor:
Boston Children's Hospital Boston Children’s Hospital