Overview

Direct Peritoneal Resuscitation in Gastroschisis

Status:
Terminated
Trial end date:
2020-10-21
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
University of Arkansas
Treatments:
Dialysis Solutions