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Direct Peritoneal Resuscitation in Gastroschisis

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ClinicalTrials.gov Identifier: NCT03205553
Recruitment Status : Terminated (COVID-19 pandemic)
First Posted : July 2, 2017
Results First Posted : December 20, 2021
Last Update Posted : December 20, 2021
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

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.


Condition or disease Intervention/treatment Phase
Gastroschisis Procedure: SoC Staged Silo Closure Drug: Peritoneal Dialysis Solution/Dextrose 1.5% Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Direct Peritoneal Resuscitation in Gastroschisis
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : May 2, 2018
Actual Study Completion Date : October 21, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard of Care (SoC) Treatment Group
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
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.
Other Name: SoC Staged Serial Reduction

Experimental: Direct Peritoneal Resuscitation (DPR) Treatment Group
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
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.
Other Name: SoC Staged Serial Reduction

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.
Other Name: Dialysate Fluid with Staged Silo Closure




Primary Outcome Measures :
  1. Days to Full Enteral Feeds [ Time Frame: Up to Hospital Discharge (average 30 days) ]
    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.


Secondary Outcome Measures :
  1. Days to Abdominal Wall Closure [ Time Frame: Up to 7 days ]
    Serial reductions are 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.

  2. Days on Total Parental Nutrition (TPN) [ Time Frame: Until Day of Discharge, an average of 29 days ]
    Enteral feeding is begun after orogastric (OG) tube output has stopped and a bowel movement has occurred. OG tube output is checked at least every 4 hours (± 30 minutes) and/or before each feeding per NICU standard practice. Initiation of feeds is a clinical decision based on decreased gastric tube output, abdominal x-rays, and passing of stool. The initiation of enteral feeds is assessed daily on morning rounds by the neonatology team. Feedings start at an average of 7 days following abdominal wall closure. The advancement of enteral feeds will be based on standard practice at ACH. Most feedings are started every six hours and advanced to every three hours as tolerated.

  3. Days to Intestinal Motility [ Time Frame: Up to 3 weeks post-closure ]
    Motility was quantified as the total number of distinct peristaltic movements visualized in each abdominal quadrant over 30 seconds. A global descriptive score of bowel activity was assigned with the following categories: no, low, normal, or hyperactive peristalsis. The present results are representative of the number of days to return to normal bowel activity.

  4. Number of Days in the Hospital [ Time Frame: Until Day of Discharge, an average of 40 days ]
    Total number of days in the hospital from birth to discharge following staged silo reduction



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Ages Eligible for Study:   0 Hours to 12 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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:

    • Characterized by increased blood lactate levels (> 5 mmol/L) on two occasions at least 6 hours apart
    • Severe metabolic acidosis with an arterial pH ≤ 7.0
    • Bicarbonate < 14 or CO2 < 12
    • Base excess of > -10 mEq/L
  • Neonatal Acute Renal Failure, defined as serum creatinine > 2.0 mg/dL with anuria in the first 12 hours of life
  • Neonatal Acute Hepatic Failure, defined as INR > 3
  • Liver function test abnormalities defined as AST > 200, ALT > 200, GGT > 100
  • Electrolyte abnormalities, defined as:

    • Sodium < 130 or > 150 mEq/L
    • Potassium < 3.0 or > 6.5 mEq/L
  • Hyperglycemia (> 150 mg/dL) or hypoglycemia (< 40 mg/dL)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03205553


Locations
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United States, Arkansas
Arkansas Childrens Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Patrick C Bonasso, MD University of Arkansas for Medical Sciences (UAMS)
Principal Investigator: Samuel Smith, MD Arkansas Children's Hospital Research Institute
  Study Documents (Full-Text)

Documents provided by University of Arkansas:
Informed Consent Form  [PDF] December 20, 2018

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03205553    
Other Study ID Numbers: 206573
First Posted: July 2, 2017    Key Record Dates
Results First Posted: December 20, 2021
Last Update Posted: December 20, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Arkansas:
Neonate
Additional relevant MeSH terms:
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Gastroschisis
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical
Dialysis Solutions
Pharmaceutical Solutions