Direct Peritoneal Resuscitation in Gastroschisis

NCT03205553 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 206573
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Neonate

Outcome Measures

Primary Outcomes (1)

• Days to Full Enteral Feeds

  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.

  Up to Hospital Discharge (average 30 days)

Secondary Outcomes (4)

• Days to Abdominal Wall Closure

  Up to 7 days

• Days on Total Parental Nutrition (TPN)

  Until Day of Discharge, an average of 29 days

• Days to Intestinal Motility

  Up to 3 weeks post-closure

• Number of Days in the Hospital

  Until Day of Discharge, an average of 40 days

Study Arms (2)

Standard of Care (SoC) Treatment Group

ACTIVE COMPARATOR

The SoC group will be placed in silo shortly after birth within 2 hours of admission to the NICU per standard practice and subsequently serially reduced in silo (staged silo reduction) until the bowel contents are at the level of fascia and deemed suitable for closure. These subjects will have no change in current clinical management by the neonatologists or pediatric surgeons.

Procedure: SoC Staged Silo Closure

Direct Peritoneal Resuscitation (DPR) Treatment Group

EXPERIMENTAL

The DPR group will be placed in silo shortly after birth within 2 hours of admission to the NICU per standard practice. At the time of silo placement for staged procedure, the JP drain will be sterilely placed intra-abdominally through the top of the silo. Subjects will be treated with adjuvant direct peritoneal resuscitation (DPR) and subsequently serially reduced in silo until the abdomen is closed (during the entirety of silo placement), which is usually four to five days.

Procedure: SoC Staged Silo Closure; Drug: Peritoneal Dialysis Solution/Dextrose 1.5%

Interventions

SoC Staged Silo Closure PROCEDURE

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.

Also known as: SoC Staged Serial Reduction

Direct Peritoneal Resuscitation (DPR) Treatment Group; Standard of Care (SoC) Treatment Group

Peritoneal Dialysis Solution/Dextrose 1.5% DRUG

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.

Also known as: Dialysate Fluid with Staged Silo Closure

Direct Peritoneal Resuscitation (DPR) Treatment Group

Eligibility Criteria

• Age: 0 Hours - 12 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of Gastroschisis
• Male or Female, any ethnicity
• Neonates \[0-27 days as defined by the Age Classification in the ICH E-11\]

You may not qualify if:

• Primary gastroschisis repair
• Vanishing gastroschisis
• Encapsulating peritoneal sclerosis
• Infants \< 2 kg and \< 34 weeks gestation
• Infants \> 12 hours at enrollment
• Severe hypotension, defined as either:
• Mean arterial blood pressure (MAP) \< gestational age in weeks, or
• Systolic blood pressure (BP) \< 45 or diastolic BP \< 20
• Severe Hypertension defined as Systolic BP \> 90 or diastolic \> 60
• Culture-positive sepsis
• Known or strongly suspected inborn errors of metabolism
• Significant cardiac disorders, including cyanotic congenital heart disease, ductal-dependent congenital heart disease, and critical congenital heart disease (lesions requiring surgery or catheter-based intervention in the first year of life)
• Respiratory failure, defined as any requirement of positive pressure ventilation at the time of enrollment, or FiO2 \> 50%
• Any other condition, that, in the opinion of the investigator, might interfere with the safe conduct of the study or place the subject at increased risk
• Lactic acidosis with at least one or more of the following:

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

Arkansas Childrens Hospital

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Gastroschisis

Interventions

Dialysis Solutions

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Dr. Patrick Bonasso
• Organization: University of Arkansas for Medical Sciences

PCBonasso@uams.edu

(501) 364-2943

Study Officials

• Patrick C Bonasso, MD

  University of Arkansas for Medical Sciences (UAMS)

  PRINCIPAL INVESTIGATOR

• Samuel Smith, MD

  Arkansas Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 only. All subjects will be placed in a silo shortly after birth and within 2 hours of admission to the NICU and subsequently serially reduced in silo with umbilical tape until the bowel contents are at the level of fascia and deemed suitable for closure.

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 2, 2017
• Study Start: February 1, 2018
• Primary Completion: May 2, 2018
• Study Completion: October 21, 2020
• Last Updated: December 20, 2021
• Results First Posted: December 20, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)