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NCT03667703 · ClinicalTrials.gov registry record · Phase 4
Stress Ulcer Prophylaxis Versus Placebo in Critically Ill Infants With Congenital Heart Disease
A Phase 4 study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
NCT03667703 is a Phase 4 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 70 participants.
The verdict
NCT03667703, a Phase 4 study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Famotidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-03-10 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03667703
The ClinicalTrials.gov registry entry for NCT03667703 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03667703 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03667703 about?
NCT03667703 is a clinical study titled "Stress Ulcer Prophylaxis Versus Placebo in Critically Ill Infants With Congenital Heart Disease". 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. Howe...
What is the current status of trial NCT03667703?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2019-03-10. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT03667703?
The interventions under investigation include: Placebo (DRUG), Famotidine (DRUG).
Who is sponsoring clinical trial NCT03667703?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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