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

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Collaborator: The Gerber Foundation
• Treatments: Famotidine; Ranitidine; Ranitidine bismuth citrate

Criteria

Inclusion Criteria:

1. < 12 months of age (including premature newborns),

2. diagnosed with congenital heart disease (including anatomic, myopathic and arrhythmic conditions),

3. received ≤ 1 dose of SUP (including histamine-2 receptor antagonists, proton pump inhibitors, and sucralfate) during current admission, AND

4. anticipated to require respiratory support for > 24 hours during their CICU stay. Respiratory support includes mechanical ventilation, non-invasive positive-pressure ventilation and high-flow oxygen therapy.

Exclusion Criteria:

1. prior use of antacids (including histamine-2 receptor antagonists, proton pump inhibitors, or sucralfate) in the past month for > 7 days,

2. active gastrointestinal bleeding,

3. active Helicobacter pylori infection,

4. administration of high-dose steroids (equivalent dosing to 15 mg/kg/day of methylprednisolone),

5. will receive ketorolac (intravenous nonsteroidal anti-inflammatory drug) during admission,

6. exposed to specific anticoagulants (high-dose aspirin, direct thrombin inhibitors and GPIIbIIIa inhibitors),

7. planned to undergo or recently has undergone gastrointestinal surgery (i.e. repair of duodenal atresia)

8. supported by extracorporeal membrane oxygenator (ECMO) or ventricular assist device (VAD),

9. currently enrolled in another intervention trial,

10. known to be allergic to H2RAs,

11. admitted for palliative care,

12. prior enrollment in the study, OR

13. primary provider declines enrollment.