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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: Completed Phase 4 study, sponsored by Boston Children's Hospital.
NCT03667703 is a Phase 4 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 70 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Feasibility will be defined by the following metrics: (1) if \>80% of eligible patients are approached for consent (screening), (2) \>20% of eligible patients are randomized (consent and enrollment), (3) \>80% of enrolled patients received first dose of study drug within 48 hours (allocation), and (4) \>80% compliance to protocol and treatment group (protocol adherence).
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 |
What the finished NCT03667703 record still lists
NCT03667703 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03667703 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03667703's enrollment target sits among peer trials
70 1043rd of 2000 higher than 931 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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