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NCT03205553 · ClinicalTrials.gov registry record · Phase 1
Direct Peritoneal Resuscitation in Gastroschisis
A Phase 1 study, sponsored by University of Arkansas.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT03205553 is a Phase 1 study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 3 participants.
The verdict
NCT03205553, a Phase 1 study, was terminated before completion, sponsored by University of Arkansas.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is a prospective, double-arm study designed to evaluate the tolerability of direct peritoneal resuscitation (DPR) in neonates with gastroschisis. The experimental arm (DPR group) will receive adjuvant DPR with standard treatment for gastroschisis (staged silo closure). The control arm (SoC group) will receive standard treatment for gastroschisis without DPR. The Research Team will prospectively enroll all neonates with the diagnosis of gastroschisis presenting to ACH within 12 hours after birth for whom consent is signed by the parent(s)/legally authorized representative (LAR). The Research Team anticipates enrolling 40 subjects at Arkansas Children's Hospital. All subjects that have their abdominal wall defect closed will be defined as having completed active participation in the study.
Interventions
- PROCEDURE SoC Staged Silo Closure
- DRUG Peritoneal Dialysis Solution/Dextrose 1.5%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2020-10-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03205553
The ClinicalTrials.gov registry entry for NCT03205553 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SoC Staged Silo Closure is the first listed.
NCT03205553 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03205553 about?
NCT03205553 is a clinical study titled "Direct Peritoneal Resuscitation in Gastroschisis". This is a prospective, double-arm study designed to evaluate the tolerability of direct peritoneal resuscitation (DPR) in neonates with gastroschisis. The experimental arm (DPR group) will receive adjuvant DPR with standard treatment for gastroschisis (staged silo closure). The control arm (SoC grou...
What is the current status of trial NCT03205553?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2018-02-01. Estimated completion is 2020-10-21.
What interventions are being tested in trial NCT03205553?
The interventions under investigation include: SoC Staged Silo Closure (PROCEDURE), Peritoneal Dialysis Solution/Dextrose 1.5% (DRUG).
Who is sponsoring clinical trial NCT03205553?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
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