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Direct Peritoneal Resuscitation in Gastroschisis

NCT03205553 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-12-20

Study results available
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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.

Conditions

  • Gastroschisis

Interventions

PROCEDURE

SoC Staged Silo Closure

Serial reductions will be performed with silastic silo placement for staged reduction using umbilical tape ties. The silo is assessed daily on morning rounds by the surgical team. Once the abdominal contents are at the level of the fascia, the abdomen is closed in the operating room. The average day to closure historically from CHND data is 5 days.

DRUG

Peritoneal Dialysis Solution/Dextrose 1.5%

Serial reductions will be performed with silastic silo placement for staged reduction with adjuvant direct peritoneal resuscitation (DPR). A JP drain will be securely placed through the top of the silo beneath the fascia at the base of the small bowel mesentery for instillation of dialysate fluid and aspiration of peritoneal fluid. The sterile syringe will then be connected to the JP drain. The dialysate fluid administered via JP drain as a bolus infusion every 6 hours until the abdominal wall is closed (generally 3-5 days), but not to exceed 7 days maximum. Fluid will be warmed at bedside using dry heat not to exceed 37°C/98°F. The initial bolus infusion will be 10 mL/kg of dialysate. If tolerated, each subsequent infusion will be increased by 10 mL/kg up to a goal infusion of 40 mL/kg (to a maximum volume of 100 mL) as tolerated. Dialysate will dwell for 1 hour after instillation of fluid. Any excess fluid will then be removed via JP drain.

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Patrick C Bonasso, MD · University of Arkansas for Medical Sciences (UAMS)

  • Samuel Smith, MD · Arkansas Children's Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Hours
Max Age
12 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2018-05-02
Completion
2020-10-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03205553 on ClinicalTrials.gov