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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: Clinical Trial Phase 1 study, sponsored by University of Arkansas.
NCT03205553 is a Phase 1 study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To demonstrate that subjects treated with DPR will have a more benign hospital course as measured by time to full enteral feeds. The primary outcome measure will be time to full feeds of 100 kcal/kg/day. This is assessed once daily on morning rounds by the neonatology team.
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 |
Why NCT03205553 stopped before completion
NCT03205553 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which SoC Staged Silo Closure is the first listed.
NCT03205553 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03205553's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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