Stress Ulcer Prophylaxis Versus Placebo in Critically Ill Infants With Congenital Heart Disease

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.

Timeline

Start

2019-03-10

Primary completion

2022-06-30

Completion

2022-06-30

Publications

• Mills KI, Albert BD, Bechard LJ, Chu S, Duggan CP, Kaza A, Rakoff-Nahoum S, Sleeper LA, Newburger JW, Priebe GP, Mehta NM. Stress Ulcer Prophylaxis Versus Placebo-A Blinded Pilot Randomized Controlled Trial to Evaluate the Safety of Two Strategies in Critically Ill Infants With Congenital Heart Disease. Pediatr Crit Care Med. 2024 Feb 1;25(2):118-127. doi: 10.1097/PCC.0000000000003384. Epub 2024 Jan 19.
• Mills KI, Albert BD, Bechard LJ, Duggan CP, Kaza A, Rakoff-Nahoum S, Vlamakis H, Sleeper LA, Newburger JW, Priebe GP, Mehta NM. Stress ulcer prophylaxis versus placebo-a blinded randomized control trial to evaluate the safety of two strategies in critically ill infants with congenital heart disease (SUPPRESS-CHD). Trials. 2020 Jun 29;21(1):590. doi: 10.1186/s13063-020-04513-w.

Drugs

Indications