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NCT03355326 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Glycerin Suppositories to Improve Bowel Function in Gastroschisis
A Phase 4 study, sponsored by Indiana University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT03355326 is a Phase 4 study that was terminated before completion, run by Indiana University. The registered enrollment target is 16 participants.
The verdict
NCT03355326, a Phase 4 study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
Gastroschisis is a congenital defect of the abdominal wall that leads to evisceration of various amounts of the abdominal organs. The mainstay of therapy is restoring continuity of the abdominal wall, either through primary closure or with a synthetic graft when primary closure is not feasible. It has been established that bowel function after repair of gastroschisis is impaired due to the aforementioned pathological processes. Previous studies have shown that the time from surgery to attaining full nutrition through enteral means is a predictor for morbidity in this population. Therefore, numerous therapeutic interventions have been proposed to help hasten bowel function and decrease the time to tolerance of total enteral nutrition. A common, but unproven, technique is the use of glycerin suppositories to stimulate bowel function. The concept of glycerin suppositories is that stimulating colonic activity through the use of the suppository will stimulate small intestinal function. The underlying concept is that improved bowel motility and reduced time to full enteral feeds will reduce the morbidity associated with this disease. While the formation/evacuation of stools is most easily monitored, the main purpose of using these suppositories is to hasten tolerance of nutrition through enteral means. While the practice of using glycerin suppositories is common in neonates, there is no literature or best-practice guidelines advocating for (or against) their use. A single previous prospective study utilizing glycerin suppositories in premature, low birth weight neonates failed to show any benefit in improving time to tolerate full enteral feeds. At this time, this is the only study investigating the use of glycerin suppositories in any neonatal population, and due to the indications (i.e. premature and low birth weight infants without surgical disease), the findings are not applicable to neonates with gastroschisis. To the authors' knowledge, there are no previous studi
Interventions
- DRUG Glycerin Suppository
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2017-10-01 |
| Est. Completion | 2020-10-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03355326
The ClinicalTrials.gov registry entry for NCT03355326 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Glycerin Suppository is the first listed.
NCT03355326 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03355326 about?
NCT03355326 is a clinical study titled "Evaluation of Glycerin Suppositories to Improve Bowel Function in Gastroschisis". Gastroschisis is a congenital defect of the abdominal wall that leads to evisceration of various amounts of the abdominal organs. The mainstay of therapy is restoring continuity of the abdominal wall, either through primary closure or with a synthetic graft when primary closure is not feasible. It ...
What is the current status of trial NCT03355326?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2017-10-01. Estimated completion is 2020-10-01.
What interventions are being tested in trial NCT03355326?
The interventions under investigation include: Glycerin Suppository (DRUG).
Who is sponsoring clinical trial NCT03355326?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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