Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT03667703
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Minute
Maximum Age:
12 Months
Study:
NCT03667703
Study Brief:
Protocol Section:
NCT03667703